tag:blogger.com,1999:blog-55068075665508781262024-02-20T20:39:06.406+00:00Tuesday1st Correspondence with the MHRA ……..Patient & Public Engagement StrategyUnknownnoreply@blogger.comBlogger20125tag:blogger.com,1999:blog-5506807566550878126.post-62565571432076312232010-02-01T00:21:00.009+00:002010-02-05T12:46:14.194+00:00Concerns over the Seroxat Group Litigation<span style="color: black;">Due to situations on my </span><a href="http://tuesday1st.blogspot.com/2009/05/doh-1998-2008-england-ssri-snri_07.html#comments"><span style="color: black;">UK: SSRI / SNRI Antidepressant Statistical Politics Blog</span></a><span style="color: black;"> and </span><a href="http://tuesday1st-mhra-ppes-correspondence.blogspot.com/2009/07/attachment-dear-mr-gregor-as-mr-bob.html"><span style="color: black;">around the internet</span></a><span style="color: black;">, I have felt unable to progress or use this blog for the purpose it was intended.</span><br />
<br />
<span style="color: black;">As a result I’m taking time out from statistics and associated issues - as yet unpublished - to facilitate publishing information appertaining to the UK Seroxat Litigation which, having been in the public domain since it was preannounced in 2001/2, is going to court this year.</span><br />
<br />
<span style="color: black;">The information encompasses the UK Government Prescription Cost Analysis (PCA) statistics - although at the time of publication of my </span><a href="http://tuesday1st.blogspot.com/"><span style="color: black;">Statistical Politics blog</span></a><span style="color: black;"> - I was unaware of one significant fact and therefore revelations were unintentional.</span><br />
<br />
<span style="color: black;">However, a few weeks after its publication, on first sight of the </span><a href="http://www.hmcourts-service.gov.uk/cms/150_14671.htm"><span style="color: black;">Seroxat Group Litigation Order no: 68</span></a><span style="color: black;"> it became glaringly obvious that inadvertently, </span><a href="http://tuesday1st.blogspot.com/2009/05/doh-1998-2008-england-ssri-snri_2963.html"><span style="color: black;">the statistics</span></a><span style="color: black;"> – not me – undermine the Litigation.</span><br />
<br />
<span style="color: black;">Since becoming aware of and involved with the SSRI drug forums in 2001, I have spoken out - not against the litigation - but in concern for those involved and anyone taking SSRI, SNRI drugs, especially those choosing to or being swapped without consideration from Seroxat to other drugs in the class including Prozac, Lustral and Efexor.</span><br />
<br />
<span style="color: black;">The statistics are, unfortunately, not the only jeopardy to the frail legal case being successful - Seroxat has a certain notoriety for being “the worst drug” in the class - but is that notoriety well-substantiated or solely due to outside influences? Do the experts agree? </span><br />
<br />
<span style="color: black;">Have the UK population been let down by the government, medicines authorities and the media? </span><br />
<br />
<span style="color: black;">The new Seroxat Litigation blog will hopefully extricate the distinct facts, clarify, assemble and publicise each in context - to let the readers decide for them selves. </span><br />
<br />
<span style="color: black;">The new blogs content will possibly adversely impact on the few hundred people who have not been culled from the originally quoted 10.000 prospective litigants ...... but the full ramifications of not speaking out will possibly impact on thousands or even millions.</span><br />
<br />
<span style="color: black;">I have no conflicting interests. </span><br />
<br />
<strong><span style="color: black; font-family: Georgia, "Times New Roman", serif;"><a href="http://the-uk-seroxat-litigation-chronicles.blogspot.com/">The UK Seroxat Litigation Chronicles</a></span></strong><span style="color: black;"> - a work in progress - can be found </span><a href="http://the-uk-seroxat-litigation-chronicles.blogspot.com/"><span style="color: black;">here.</span></a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-59011203344141331052009-08-18T22:57:00.003+01:002009-08-18T23:04:21.354+01:00From: Gregor, Simon - Sent: Monday, August 17, 2009 10:09 AM - Subject: Response to Freedom Of Information request ref 09/180<a href="http://farm4.static.flickr.com/3578/3834273991_cd238f8fd5_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 590px; DISPLAY: block; HEIGHT: 644px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3578/3834273991_cd238f8fd5_o.jpg" /></a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-19883358926775378732009-07-12T11:59:00.013+01:002009-07-15T09:36:13.124+01:00Conclusion of Informal Correspondence<span style="font-size:78%;color:#ffffff;"><strong><span style="font-size:130%;">_<span style="font-family:Arial;"><span style="color:#ffffff;">_<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></span></span> </span></strong><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="font-size:130%;">I received no replies to my last two emails, however, I did receive two read receipts for each so presume that Mr Gregor and M-s Smith both read them, the receipts can be published if anyone wants to see them; as I did not receive any guidance from the MHRA with regard redactions the emails have been published in tact other than redaction of my details.<o:p></o:p></span></strong></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="font-family:trebuchet ms;color:#ffffff;"><strong>_</strong></span></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="font-size:130%;">I will answer the hovering question - “why redact my details?”<o:p></o:p></span></strong></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="font-family:trebuchet ms;color:#ffffff;"><strong>_</strong></span></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><span style="font-size:100%;"><strong><span style="font-size:130%;">Quite simply I don’t see the need for them to be there, if a question or issue is raised that is pertinent and of concern to the wellbeing of the whole population – who asks that question or raises that issue is immaterial - as long as they're asked and raised.</span> <o:p></o:p></strong></span></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="font-family:trebuchet ms;font-size:100%;color:#000000;"><strong></strong></span></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="font-family:trebuchet ms;color:#ffffff;"><strong>_</strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="font-size:130%;">Also - I have no vested interest for personal or financial gain in collecting or disclosing facts and information.<o:p></o:p></span></strong></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="font-family:trebuchet ms;color:#ffffff;"><strong>_</strong></span></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="font-size:130%;">I did not become involved with the prescription drug boards or any other issue for self promotion – something another person involved just can’t seem to get their head round.<o:p></o:p></span></strong></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="font-family:trebuchet ms;color:#ffffff;"><strong>_</strong></span></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#000000;"><strong><span style="font-family:trebuchet ms;font-size:100%;"><span style="font-size:130%;">Although from what has transpired since I published my first Blog “Tuesday1st UK: SSRI / SNRI Antidepressant Statistical Politics” and my name was brought into the MHRA PPES arena - his 'need' to know personal details is blatantly nothing to do with the subjects raised</span>.</span><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><o:p><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="color:#ffffff;">_</span> </strong></span></span></o:p></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="color:#000000;"><span style="font-family:trebuchet ms;font-size:130%;"><strong>Now the informal correspondence between Mr Gregor and myself have been published,</strong></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><span style="font-family:trebuchet ms;"><strong><span style="color:#ffffff;">_<o:p></o:p></span></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Trebuchet MS';"><o:p><span style="color:#000000;"></span></o:p></span><span style="font-family:'Trebuchet MS';"><span style="font-family:trebuchet ms;font-size:130%;color:#000000;"><strong>( which has hopefully cleared - referring to the subject matter thus far - the unsavoury dross and detritus of Mr Fiddaman’s actions ) </strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><o:p><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="color:#ffffff;">_</span> </strong></span></span></o:p></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#000000;"><span style="font-family:trebuchet ms;"><strong><span style="font-size:130%;">o<span style="font-family:'Trebuchet MS';">nce Mr Gregor is back in office I intend, on a more formal footing, to raise with him the areas and issues of concern referred to in my opening post and acceptance; these will cross link to dialogue already instigated with pharmacovigilance and FoI questions I have asked. </span></span></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><span style="font-family:Trebuchet MS;color:#ffffff;">_</span></strong></p><span style="font-family:Trebuchet MS;"><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS';font-family:Arial;" ><span style="color:#000000;"><span style="font-size:100%;"><strong>NB </strong>– Before someone passes comment. I know there is an error in my last email which should have read Correspondence not ‘Conversations’, there are others too throughout the correspondence, but that’s dyslexia for you!<o:p></o:p></span></span></span></p></span></span>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-67142369302366313772009-07-12T08:20:00.005+01:002009-07-13T13:15:24.065+01:00Sent: Wednesday, July 08, 2009 2:01 PM - Subject: Re: Patient and Public Engagement<span style="font-size:78%;color:#ffffff;">_</span><br /><a href="http://farm3.static.flickr.com/2543/3710633989_8b0283a528_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 589px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2543/3710633989_8b0283a528_o.jpg" /></a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-24462014130634642752009-07-12T07:51:00.006+01:002009-07-13T13:16:20.300+01:00Sent: Wednesday, July 01, 2009 11:40 AM - Subject: Re: Response to Freedom Of Information request ref 09/180<span style="font-size:78%;color:#ffffff;">_</span><br /><a href="http://farm3.static.flickr.com/2545/3711205888_93ff8d9f27_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 576px; DISPLAY: block; HEIGHT: 499px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2545/3711205888_93ff8d9f27_o.jpg" /></a><a href="http://farm3.static.flickr.com/2673/3711294826_70dca9cf4e_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 536px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2673/3711294826_70dca9cf4e_o.jpg" /></a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-80124707109197009432009-07-12T00:39:00.006+01:002009-07-12T15:34:16.229+01:00From: Gregor, Simon - Sent: Wednesday, June 10, 2009 12:11 PM - Subject: Response to Freedom Of Information request ref 09/180<span style="font-size:78%;color:#ffffff;">_</span><br /><a href="http://farm3.static.flickr.com/2466/3710344323_25585a959e_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 468px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2466/3710344323_25585a959e_o.jpg" /></a><a href="http://farm3.static.flickr.com/2530/3711154268_d79b3f9191_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 452px; DISPLAY: block; HEIGHT: 641px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2530/3711154268_d79b3f9191_o.jpg" /></a><a href="http://farm4.static.flickr.com/3530/3711153952_2b562a444f_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 452px; DISPLAY: block; HEIGHT: 641px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3530/3711153952_2b562a444f_o.jpg" /></a><br /><p><a href="http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con049185.pdf"><span style="font-size:78%;">http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con049185.pdf</span></a></p><p><span style="font-size:78%;"></span> </p>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-79107636419448247372009-07-12T00:22:00.011+01:002009-07-12T10:00:52.475+01:00From: Gregor, Simon - Sent: Friday, June 05, 2009 11:27 AM - Subject: Out of Office AutoReply: Patient and Public Engagement<span style="color:#ffffff;">_</span><br /><a href="http://farm3.static.flickr.com/2499/3710343771_08c1bf801c_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 170px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2499/3710343771_08c1bf801c_o.jpg" /></a><span style="font-family:Tahoma;font-size:10;color:#333333;"><span style="font-size:100%;">As it was by then Friday, after receipt of the out of office notice and being concerned about publishing the informal emails without Mr Gregor knowing; I called Mr Gregors colleague and spoke with her about the situation, she read the email I directed her to, sent me a read receipt, marked the email urgent to ensure Mr Gregor would notice it.</span></span><br /><br /><div><a href="http://farm3.static.flickr.com/2469/3710343985_1fc044f8a5_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 229px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2469/3710343985_1fc044f8a5_o.jpg" /></a> <span style="font-family:Tahoma;font-size:10;color:#333333;"><span style="font-size:100%;">He called a little later that day and we discussed the situation; as our contact at this point was on an informal basis this call will not be transcript or published. <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></span></span><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Tahoma;font-size:10;color:#333333;"><o:p><span style="font-size:100%;"></span></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Tahoma;font-size:10;color:#333333;"><span style="font-size:100%;">During the conversation it was mutually understood that our correspondence thus far was informal, that I was reluctant to publish - but felt I had been left no choice. <span style="mso-spacerun: yes"></span>Mr Gregor seemed to appreciate my making contact to inform him of my intention to publish, rather than him just coming across the Blog or having it brought to his attention by a third party.<span style="mso-spacerun: yes"> </span><o:p></o:p></span></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="font-family:Tahoma;font-size:10;color:#333333;"><o:p><span style="font-size:100%;"></span></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Tahoma;font-size:10;color:#333333;"><span style="font-size:100%;">Our conversation ended on the gist that although the correspondence thus far was informal the decision whether to publish was left to my discretion as to whether I felt it necessary.<span style="mso-spacerun: yes"> </span>Because of my reluctance about publishing I decided to stalled to see if the internet situation resolved – which it didn’t - if anything it escalated. <o:p></o:p></span></span></p><div><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"></p></div></div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-33778290223146446402009-07-11T14:45:00.015+01:002009-07-11T20:00:10.581+01:00Sent - Date: Friday, June 5, 2009 11:27 AM - Subject: Re: Patient and Public Engagement<strong><u><span style="font-family:Comic Sans MS;font-size:85%;"></span></u></strong><br /><a href="http://farm4.static.flickr.com/3510/3710024624_2b0bcd3242_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 578px; DISPLAY: block; HEIGHT: 620px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3510/3710024624_2b0bcd3242_o.jpg" /></a> <div><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';font-size:10;" ><span style="FONT-FAMILY: 'Comic Sans MS'; mso-fareast-language: EN-GB; mso-ansi-language: EN-GB; mso-bidi-: AR-SA; mso-fareast-font-family: 'Times New Roman'font-family:'Times New Roman';font-size:10;" ><strong><u></u></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';font-size:10;" ><span style="FONT-FAMILY: 'Comic Sans MS'; mso-fareast-language: EN-GB; mso-ansi-language: EN-GB; mso-bidi-: AR-SA; mso-fareast-font-family: 'Times New Roman'font-family:'Times New Roman';font-size:10;" ><strong><u></u></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><span style="FONT-FAMILY: 'Comic Sans MS'; mso-fareast-language: EN-GB; mso-ansi-language: EN-GB; mso-bidi-: AR-SA; mso-fareast-font-family: 'Times New Roman'font-family:'Times New Roman';font-size:85%;" ><strong><u></u></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><span style="FONT-FAMILY: 'Comic Sans MS'; mso-fareast-language: EN-GB; mso-ansi-language: EN-GB; mso-bidi-: AR-SA; mso-fareast-font-family: 'Times New Roman'font-family:'Times New Roman';" ><strong><u>Attachment</u></strong></span></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >Dear Mr Gregor <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >As Mr Bob Fiddaman has seen fit to escalate his targeting of me, and done exactly what I predicted and informed you he would do in my email of May 22<sup>nd</sup> 09– <o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><span style="mso-spacerun: yes"></span>“</span></i><i style="mso-bidi-font-style: normal"><u><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">Again, I stress, I am not asking you to comment</span></u></i><i style="mso-bidi-font-style: normal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;"> - but I do need to question your discernment in discussing matters with Mr Fiddaman <u>and <b style="mso-bidi-font-weight: normal">by doing so giving him license to put others (including myself) in a compromised situation that he can - and will use for further self promotion and / or castigation - depending whether those put forward choose to work with you - or not.”</b></u></span></i><b style="mso-bidi-font-weight: normal"><i style="mso-bidi-font-style: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></u></i></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >by posting the following <o:p></o:p></span></p><br /><p><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" ><a href="http://tuesday1st.wordpress.com/2009/06/03/delusional-anti-seroxat-campaigner-rants/">http://tuesday1st.wordpress.com/2009/06/03/delusional-anti-seroxat-campaigner-rants/</a><o:p></o:p></span></p><p><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" >“See <a href="http://www.mhra.gov.uk/home/groups/comms-sp/documents/publication/con025700.pdf">minutes</a> of meeting Bob Fiddaman had with MHRA.</span></i></p><p><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" >Ask yourself why Mardi Bennett refuses to acknowledge that the meeting was about ALL SSRi’s.<o:p></o:p></span></i></p><p><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" >Bennett has been offered the chance to meet with the MHRA, in fact, it was <a href="http://fiddaman.blogspot.com/2009/05/15th-may-meeting-with-mhra-birmingham.html">Bob Fiddaman who recommended they speak with her</a>. It is not known if she has the balls to face them face to face. I’m sure if she ever does she will repeatedly harp on about the </span></i><em><span style="FONT-STYLE: normal; mso-ansi-language: EN; mso-bidi-font-style: italicfont-family:'Comic Sans MS';" lang="EN" >’single issue of Seroxat’.</span></em><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" ><o:p></o:p></span></i></p><p><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" >Mardi Bennett continues to rant and rave about Seroxat campaigners, despite evidence that her fixation, Bob Fiddaman, has tried to make changes with ALL SSRi’s.<o:p></o:p></span></i></p><p><i style="mso-bidi-font-style: normal"><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" >Is it because the minutes to the MHRA meeting do not fit in with her blinkered views that she still continues in her quest to fit peices of a jigsaw together that aren’t actually there?”</span></i><span style="mso-ansi-language: EN;font-family:'Comic Sans MS';" lang="EN" > </span></p><p><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >on a blog he has started specifically for the purpose on June 2<sup>nd</sup> 09 <o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><a href="http://tuesday1st.wordpress.com/">http://tuesday1st.wordpress.com/</a><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><u><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p><span style="TEXT-DECORATION: none"></span></o:p></span></u></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >after I wrote an explanatory post , June 2<sup>nd</sup> 09, uksurvivors group due to concerns about another person - “Steve” – who had become involved and had been directed by Mr Fiddaman to read there -<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><a href="http://groups.yahoo.com/group/uksurvivors/message/44709">http://groups.yahoo.com/group/uksurvivors/message/44709</a><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >“Steve” - obviously uneducated in the arena he had been baited into by Mr Bob Fiddaman, of his deleterious reputation and calculated, devious manipulation was probably expecting --after complying with a request for more information to “put the records straight” -- the posts about the family to be removed - NOT just edited!<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><u><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >Stressing again that I am not asking you to comment</span></u><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >, but being aware that you are following the Blogs and therefore Mr Bob Fiddamans activities -,I refer you to the following two Blogs <o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><a href="http://strangfordbryce.blogspot.com/">http://strangfordbryce.blogspot.com/</a><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><a href="http://jeremybryce1953.wordpress.com/"><span style="color:#800080;">http://jeremybryce1953.wordpress.com/</span></a><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >which he has claimed ownership of by way of stating he was editing one: -<o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:Arial;"><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:Arial;"><a href="http://farm4/">http://farm4/</a>. static.flickr. com/3601/ 3586075255_ 55b2b82a04_ o.jpg<o:p></o:p></span></p><br /><a href="http://farm4.static.flickr.com/3237/3709352101_4224fd66ea_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 537px; DISPLAY: block; HEIGHT: 520px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3237/3709352101_4224fd66ea_o.jpg" /></a> <p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';font-size:10;" ></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >where he has targeted others family members and myself.<o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >In direct response to a question from another member of the Yahoo groups I posted the following on June 3<sup>rd</sup> 09 <o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >h<a href="http://groups.yahoo.com/group/uksurvivors/message/44782"><span style="color:#800080;">ttp://groups.yahoo.com/group/uksurvivors/message/44782</span></a><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >when I didn’t receive a response by the following day, June 4<sup>th</sup>, I copied it to two other boards I knew the questioner posted on, including the one “Steve” had been directed too.<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" ><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" >Mr Fiddamans vitriolic attack --including his starting his Tuesday1st blog-- I feel leaves me no option but to publish our correspondence to clarify my position, either on my blog or on a more permanent fixture; Where if taken forward will be a public record befitting discussions related to </span><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">the MHRA Public and Patient Engagement Strategy (PPES).<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;"><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">I appreciate the privacy aspect of this decision, but</span><span style="mso-ansi-language: EN-GB;font-family:'Comic Sans MS';" > trust this will not be met with any objections a</span><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">s all correspondence about the MHRA PPES, can be requested under the Freedom of Information Act, used and quoted -- usually out of context -- by others.<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;"><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">I would also appreciate your letting me know if there is anything you would like redacted from our correspondence before it is published, which I plan to do at the weekend. <o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;">Kind Regards <o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;"><strong>Redacted</strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-US" style="font-family:'Comic Sans MS';color:black;"><o:p></o:p></span></p><br /><p style="MARGIN: 0cm 0cm 0pt; BACKGROUND: #e4e4e4" class="MsoNormal"><b><span lang="EN-US" style="font-family:Arial;color:black;">From:</span></b><span lang="EN-US" style="font-family:Arial;color:black;"> <a title="Simon.Gregor@mhra.gsi.gov.uk" href="http://webmail.ntlworld.com/do/mail/message/mailto?to=Simon.Gregor%40mhra.gsi.gov.uk" target="_blank">Gregor, Simon</a> <o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt; BACKGROUND: white" class="MsoNormal"><b><span lang="EN-US" style="font-family:Arial;color:black;">To: Redacted</span></b><span lang="EN-US" style="font-family:Arial;color:black;"><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt; BACKGROUND: white" class="MsoNormal"><b><span lang="EN-US" style="font-family:Arial;color:black;">Sent:</span></b><span lang="EN-US" style="font-family:Arial;color:black;"> Tuesday, May 29, 2009 12:28 PM<o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt; BACKGROUND: white" class="MsoNormal"><b><span lang="EN-US" style="font-family:Arial;color:black;">Subject:</span></b><span lang="EN-US" style="font-family:Arial;color:black;"> RE: Patient and Public Engagement</span></p><p style="MARGIN: 0cm 0cm 0pt; BACKGROUND: white" class="MsoNormal"></p></div>Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-5506807566550878126.post-91292529075848891102009-07-10T21:08:00.005+01:002009-07-11T15:19:00.831+01:00Sent: Sunday, May 31, 2009 10:22 AM - Subject: Re: Patient and Public Engagement<a href="http://farm4.static.flickr.com/3453/3708146834_9690842c98_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 574px; DISPLAY: block; HEIGHT: 504px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3453/3708146834_9690842c98_o.jpg" /></a> <a href="http://farm4.static.flickr.com/3453/3708146834_9690842c98_o.jpg"><span style="font-size:78%;">http://farm4.static.flickr.com/3453/3708146834_9690842c98_o.jpg</span></a><span style="font-size:78%;"><img class="gl_photo" border="0" alt="Add Image" src="http://www.blogger.com/img/blank.gif" /></span>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-61036573377345777332009-07-09T22:45:00.005+01:002009-07-10T20:44:58.661+01:00From: Gregor, Simon - Sent: Friday, May 29, 2009 12:38 PM - Subject: Patient and Public Engagement<a href="http://farm3.static.flickr.com/2547/3705349386_c9324bd9ff_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 605px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2547/3705349386_c9324bd9ff_o.jpg" /></a><a href="http://farm4.static.flickr.com/3481/3704541413_441885b87b_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 545px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3481/3704541413_441885b87b_o.jpg" /></a><a href="http://farm3.static.flickr.com/2547/3705349386_c9324bd9ff_o.jpg"><span style="font-size:78%;">http://farm3.static.flickr.com/2547/3705349386_c9324bd9ff_o.jpg</span></a><span style="font-size:78%;"><br /></span><div><div><div><div><a href="http://farm4.static.flickr.com/3481/3704541413_441885b87b_o.jpg"><span style="font-size:78%;">http://farm4.static.flickr.com/3481/3704541413_441885b87b_o.jpg</span></a></div><div></div></div></div></div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-65684154444434789602009-07-09T02:51:00.009+01:002009-07-10T09:54:36.923+01:00Sent: Friday, May 22, 2009 9:19 PM - Subject: Re: Meeting with Mr Bob Fiddaman 15/05/09<a href="http://farm4.static.flickr.com/3495/3704331399_f6aec34e97_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 633px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3495/3704331399_f6aec34e97_o.jpg" /></a><a href="http://farm3.static.flickr.com/2624/3705141128_f7b8425e32_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 575px; DISPLAY: block; HEIGHT: 527px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2624/3705141128_f7b8425e32_o.jpg" /></a><a href="http://farm4.static.flickr.com/3495/3704331399_f6aec34e97_o.jpg"><span style="font-size:78%;">http://farm4.static.flickr.com/3495/3704331399_f6aec34e97_o.jpg</span></a><br /><span style="font-size:78%;"><a href="http://farm3.static.flickr.com/2624/3705141128_f7b8425e32_o.jpg">http://farm3.static.flickr.com/2624/3705141128_f7b8425e32_o.jpg</a></span><br /><div> </div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-51157360508893401532009-07-09T02:46:00.004+01:002009-07-09T19:27:51.401+01:00From: MHRA Information Centre - Sent: Thursday, May 21, 2009 9:48 AM - Subject: FOI 09/180 - RE: Freedom of Information Request - Meeting 15/05/09<a href="http://farm4.static.flickr.com/3502/3701900835_481271dcc1_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 579px; DISPLAY: block; HEIGHT: 511px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3502/3701900835_481271dcc1_o.jpg" /></a><a href="http://farm4.static.flickr.com/3502/3701900835_481271dcc1_o.jpg"><span style="font-size:78%;">http://farm4.static.flickr.com/3502/3701900835_481271dcc1_o.jpg</span></a>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-84075285467383716252009-07-09T02:39:00.005+01:002009-07-15T09:00:31.740+01:00From: Gregor, Simon - Sent: Tuesday, May 19, 2009 8:44 AM - Subject: RE: Meeting with Mr Bob Fiddaman 15/05/09<a href="http://farm4.static.flickr.com/3427/3702769246_c1b2051c9b_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 579px; DISPLAY: block; HEIGHT: 473px; CURSOR: hand" border="0" alt="" src="http://farm4.static.flickr.com/3427/3702769246_c1b2051c9b_o.jpg" /></a> <a href="http://farm4.static.flickr.com/3427/3702769246_c1b2051c9b_o.jpg"><span style="font-size:78%;">http://farm4.static.flickr.com/3427/3702769246_c1b2051c9b_o.jpg</span></a><br /><div></div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-86576105732714918602009-07-08T23:47:00.002+01:002009-07-08T23:52:16.363+01:00Sent: Monday, May 18, 2009 8:58 PM - Subject: Re: Meeting with Mr Bob Fiddaman 15/05/09<a href="http://farm3.static.flickr.com/2435/3701877017_b6ec0242a6_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 579px; DISPLAY: block; HEIGHT: 526px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2435/3701877017_b6ec0242a6_o.jpg" /></a> <div><span style="font-size:78%;"></span> </div><div><span style="font-size:78%;"><a href="http://farm3.static.flickr.com/2435/3701877017_b6ec0242a6_o.jpg">http://farm3.static.flickr.com/2435/3701877017_b6ec0242a6_o.jpg</a></span></div><div> </div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-54304261671595844452009-07-08T12:17:00.003+01:002009-07-08T12:29:35.677+01:00From: Gregor, Simon - Sent: Monday, May 18, 2009 2:05 PM - Subject: RE: Meeting with Mr Bob Fiddaman 15/05/09<a href="http://farm3.static.flickr.com/2477/3700805618_122288bcf8_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 582px; DISPLAY: block; HEIGHT: 640px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2477/3700805618_122288bcf8_o.jpg" /></a> <div></div><div><a href="http://farm3.static.flickr.com/2477/3700805618_122288bcf8_o.jpg"><span style="font-size:78%;">http://farm3.static.flickr.com/2477/3700805618_122288bcf8_o.jpg</span></a> </div><div> </div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-55496475658550708692009-07-08T08:23:00.005+01:002009-07-15T09:01:30.677+01:00Sent: Monday, May 18, 2009 1:24 PM - Subject: Meeting with Mr Bob Fiddaman 15/05/09<a href="http://farm3.static.flickr.com/2448/3698833527_ef48555efa_o.jpg"><span style="font-size:78%;"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 576px; DISPLAY: block; HEIGHT: 642px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2448/3698833527_ef48555efa_o.jpg" /></span></a><span style="font-size:78%;"> </span><a href="http://farm3.static.flickr.com/2448/3698833527_ef48555efa_o.jpg"><span style="font-size:78%;">http://farm3.static.flickr.com/2448/3698833527_ef48555efa_o.jpg</span></a><br /><div></div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-67853612778265757172009-07-07T23:05:00.006+01:002009-07-08T12:30:16.633+01:00Sent: Monday, May 18, 2009 12:53 PM - Subject: Freedom of Information Request - Meeting 15/05/09<a href="http://farm3.static.flickr.com/2583/3698766219_54c1af460a_o.jpg"><img style="TEXT-ALIGN: center; MARGIN: 0px auto 10px; WIDTH: 577px; DISPLAY: block; HEIGHT: 543px; CURSOR: hand" border="0" alt="" src="http://farm3.static.flickr.com/2583/3698766219_54c1af460a_o.jpg" /></a> <div><a href="http://farm3.static.flickr.com/2583/3698766219_54c1af460a_o.jpg"><span style="font-size:78%;">http://farm3.static.flickr.com/2583/3698766219_54c1af460a_o.jpg</span></a><a href="http://farm3.static.flickr.com/2552/3699403008_971f8f84e2_o.jpg"></a></div>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-79489679585735781612009-07-03T08:24:00.021+01:002009-07-06T12:23:36.235+01:00Introduction: PPES invitation acceptance, decision and reason to document correspondence with the MHRA<span style="font-family:Comic Sans MS;"> <p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:'Times New Roman';font-size:12;"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></span></p><span lang="EN-GB"><o:p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#ffffff;" lang="EN-GB" >_</span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" >After a great deal of consideration, written and verbal consultation with the Mr Simon Gregor the </span></b><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-fareast-language: EN-USfont-family:Arial;" lang="EN-GB" >Medicines and Healthcare products Regulatory Agency (</span></b><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" >MHRA) Director of Communications – I am publishing the following correspondence between him and myself. </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >The Patient and Public Engagement Strategy (PPES) is - as its title states – an official contrivance to engage Patients and the Public – therefore of Patient and Public interest.</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"></span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#ffffff;" lang="EN-GB" ><o:p>_</o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >Without passing any judgement on Simon Gregor or the MHRA, I still don’t really see how the PPES - a public relations (PR) exercise - is going to improve the areas of medicines control and the efficacy and safety of the drugs being licensed. </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >However, as Simon Gregor has eloquently stated in his correspondence, he see’s the function of the MHRA communication department as much about listening, as it is about disseminating information;</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';color:#ffffff;">_</span></b><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><em><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >in theory this is commendable, but I feel some apprehension insofar as – unless there is a major shift in the industry devised regulatory paradigm the MHRA work under at present – </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></em></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><em><span style="color:#ffffff;">_<o:p></o:p></span></em></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p><em></em></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><em><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >and changes in Government legislated regulations which facilitate the MHRA - and therefore the industry it self-regulates, free reign without any official checks and balances, and answerable to no one –</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></em></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><em><span style="color:#ffffff;">_<o:p></o:p></span></em></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p><em></em></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><em><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >there will be little improvement in the service and protection it affords patients, in prescription drug safety and efficacy monitoring, and no protection or channel for recourse or recompense when things go wrong - and things <u>do</u> go wrong. </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></em></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >This is a fact NICE<span style="font-size:78%;">(1)</span>, the MHRA, NHS and Government are acutely aware of and freely admit to - as all medicines are registered, licensed and monitored for efficacy and safety on the merit of risk-benefit profile ratios. </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >There are several areas where there appear to be opportunities for improvement in the current system, unless these are explored and avenues opened to facilitate change the situation will stagnate and patients will remain in the same vulnerable circumstance. </span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >As Simon Gregor has offered the opportunity for discourse I have -- after deliberation -- written and accepted his invitation to discuss these issues with him, however, due to my health limitations and time restrictions meeting on a personal basis will not be possible at this time;</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >so am doing so on the understanding that current discussions will be carried out through the written medium or by telephone, and all correspondence and transcripts of telephone calls / discussions will be published here for open public record.</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >This will raise public awareness to areas of concern within the medicine regulatory system, give a record of the level of commitment to involving Patients and the Public and hopefully show that those areas of concern can and will be improved -– or not as the case may be.</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >Publishing this correspondence will also offset others unnecessarily engaging the MHRA FoI (Freedom of Information) department with requests for information, stop erroneous speculation or resulting replies and items being quoted out of context, misinterpreted and otherwise exploited.</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >Having discussed with Simon Gregor publishing our informal introductory basis correspondence thus far, I would like to make point that they are only being published to put the records straight with regard the current circumstance;</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" >whereby the contemptuous, disrespectful activities of Mr Bob Fiddaman of the fiddaman.blogspot continues – along with his stalking and harassment, in an attempt to undermine, intimidate and discredit me - for some warped perverse reason known only to himself.</span></strong></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><strong><span style="color:#ffffff;">_<o:p></o:p></span></strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p><strong></strong></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><strong><span style="color:#333333;">Whilst eager to involve Patients and the Public, the MHRA being aware that the situation has arisen in part due to their involvement, appear to have done nothing to assuage the situation, despite that involvement being used as ammunition in the unfounded, vitriolic if fanciful, venomous attacks.<o:p></o:p></span></strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';color:#333333;" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" >In taking up this opportunity for discussions with the MHRA I am under no illusions - but feel it would be prudent for other Patients and members of the Public to approach any PPES<span style="font-size:78%;">(2)</span></span></b><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" >, PPIP</span></b><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';font-size:78%;" lang="EN-GB" >(3)</span><b style="mso-bidi-font-weight: normal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" > with caution and consideration to a lack of concern by and support - if need arises - from the lead organisations.</span></b><b style="mso-bidi-font-weight: normal"><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></b></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#ffffff;"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><strong>_</strong></span><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" > <o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-fareast-language: EN-US;font-family:trebuchet ms;font-size:85%;color:#333333;" lang="EN-GB" ><o:p></o:p></span></p><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-fareast-language: EN-US;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-family:trebuchet ms;"><strong><span style="font-size:85%;"><span style="color:#666666;">Acronyms:<o:p></o:p></span></span></strong></span></span></p><p style="TEXT-INDENT: -36pt; MARGIN: 0cm 0cm 0pt 54pt; mso-list: l0 level1 lfo1; tab-stops: list 54.0pt" class="MsoNormal"><span style="font-family:trebuchet ms;"><strong><span style="font-size:85%;"><span style="color:#666666;"><span style="mso-list: Ignore">1<span style="FONT: 100% 'Times New Roman'"> </span></span>The National Institute for Clinical Excellence<o:p></o:p></span></span></strong></span></p><p style="TEXT-INDENT: -36pt; MARGIN: 0cm 0cm 0pt 54pt; mso-list: l0 level1 lfo1; tab-stops: list 54.0pt" class="MsoNormal"><span style="font-family:trebuchet ms;"><strong><span style="font-size:85%;"><span style="color:#666666;"><span style="mso-list: Ignore">2<span style="FONT: 7pt 'Times New Roman'"> </span></span>Patient and Public Engagement Strategy<o:p></o:p></span></span></strong></span></p><p style="TEXT-INDENT: -36pt; MARGIN: 0cm 0cm 0pt 54pt; mso-list: l0 level1 lfo1; tab-stops: list 54.0pt" class="MsoNormal"><strong><span style="font-size:85%;"><span style="color:#333333;"><span style="color:#666666;"><span style="mso-list: Ignore"><span style="font-family:trebuchet ms;">3<span style="FONT: 7pt 'Times New Roman'"> </span></span></span><span style="font-family:trebuchet ms;">Patient and Public Involvement Program</span></span> <o:p></o:p></span></span></strong></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-size:85%;"></span></span></p><p style="TEXT-INDENT: -36pt; MARGIN: 0cm 0cm 0pt 54pt; mso-list: l0 level1 lfo1; tab-stops: list 54.0pt" class="MsoNormal"></o:p></span></p></span>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-56862749462483473282009-06-21T07:53:00.015+01:002009-07-05T20:06:04.775+01:00MHRA: Communications Strategy<p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:trebuchet ms;"></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:trebuchet ms;color:#ffffff;">_</span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN;font-family:Arial;" lang="EN" >Communications Strategy</span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-GB" style="font-family:'Trebuchet MS';font-size:78%;color:#ffffff;"><strong>_</strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-GB" style="font-family:'Trebuchet MS';color:#333333;"><strong>Progression and development of the MHRA Communication Strategy following it’s Summer 2005 introduction after publication of The "House of Commons, Health Committee’s examination into The Influence of the Pharmaceutical Industry" - initiated June 2004 - report published April 5th 2005.</strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Trebuchet MS;"><strong><span style="font-size:78%;color:#ffffff;">_</span></strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-GB" style="font-family:'Trebuchet MS';"><a href="http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf"><span style="font-size:78%;color:#800080;">http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf</span></a></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Trebuchet MS;font-size:78%;color:#ffffff;">_</span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-family:Trebuchet MS;font-size:78%;color:#ffffff;">_</span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="font-size:0;"></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><u><span lang="EN-GB" style="font-family:'Trebuchet MS';font-size:10;"><span style="font-size:100%;"><span style="color:#000000;"><span style="color:#000000;">MHRA Communications Strategy Summer 2005- April 2007: an Agency-wide approach to communication</span>.</span></span></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><span style="font-family:Trebuchet MS;"><span style="font-size:78%;"><span style="color:#ffffff;"><u>_</u><span lang="EN-GB">_<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></span></span></span></span></strong></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><span style="font-size:100%;"><span style="color:#000000;">“</span><span style="color:#333333;">The MHRA is responsible for safeguarding public health by making sure that medicines and medical devices work, and are acceptably safe. If it is to be successful in this mission, the Agency must effectively communicate accurate and timely information about the benefits and risks of medicines and medical devices to key stakeholders, including the public, patients, healthcare professionals, researchers and industry.<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="font-size:100%;"><span style="color:#333333;">Communications is therefore mission critical for the Agency. In 2005, the new Communications Division drew together a first communications strategy for the Agency. There have been significant improvements in the Agency’s communications through the implementation of this strategy, particularly in relation to:<o:p></o:p></span></span></span></b></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><span style="font-size:100%;"><span style="color:#333333;">media handling, including the creation of an in-house Press Office<o:p></o:p></span></span></span></b></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><span style="font-size:100%;"><span style="color:#333333;">website development, including the launch of a single unified website<o:p></o:p></span></span></span></b></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><span style="font-size:100%;"><span style="color:#333333;">understanding stakeholder needs, including commissioning of detailed market research work to help us understand better the perceptions of our stakeholders<o:p></o:p></span></span></span></b></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;" lang="EN" ><span style="font-size:100%;"><span style="color:#333333;"><span style="color:#333333;">conferences and events.</span></span><span style="color:#000000;">”</span></span></span></b></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><u><span lang="EN-GB" style="font-family:'Trebuchet MS';"><a href="http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2018123&RevisionSelectionMethod=Latest"><span style="font-size:78%;">http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2018123&RevisionSelectionMethod=Latest</span></a><o:p></o:p></span></u></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><o:p><span style="font-size:78%;color:#ffffff;">__ </span></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><o:p><span style="font-size:78%;color:#ffffff;">__</span></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><u><span lang="EN-GB" style="font-family:'Trebuchet MS';font-size:10;"><span style="font-size:100%;color:#000000;">Communications Strategy April 2007 – March 2010</span></span></u></strong></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:78%;color:#ffffff;" lang="EN" >_</span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;color:#555555;" lang="EN" ><span style="font-size:100%;"><span style="color:#000000;">“</span><span style="color:#333333;">Our second Communications Strategy, covering the period until March 2010, briefly reviews the current situation in relation to Agency communications, and the evidence informing future development. It sets out the wider business context for communications activity, before establishing aims, priorities and actions for the three-year period.”</span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span lang="EN-GB" style="font-family:'Trebuchet MS';color:#333333;"><o:p><span style="font-size:78%;"><span style="color:#ffffff;">_</span> </span></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span lang="EN-GB" style="font-family:'Trebuchet MS';color:#333333;"><a href="http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031469&RevisionSelectionMethod=Latest"><span style="font-size:78%;">http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2031469&RevisionSelectionMethod=Latest</span></a><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="font-size:78%;color:#ffffff;">_</span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;font-size:10;color:#333333;" lang="EN" ><span style="font-size:100%;"><span style="font-size:78%;"><span style="color:#ffffff;">__</span><br /></span><u><span style="color:#000000;">Patient and Public Engagement Strategy April 2009 - March 2011<o:p></o:p></span></u></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><o:p><span style="TEXT-DECORATION: none"></span></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="font-size:78%;color:#ffffff;">_</span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#000000;">“</span><span style="color:#333333;">The MHRA has embarked on a new programme of activity to engage patients and the public in its work and the decisions it makes. The Agency’s first Patient and Public Engagement strategy, covering the period until March 2011, sets out the vision and strategic priorities in this area, and identifies a range of activities that will help build the Agency’s capacity and capability to successfully engage with patients and the public.</span><span style="color:#000000;">”</span><br /></span></b><b style="mso-bidi-font-weight: normal"><span lang="EN-GB" style="font-family:'Trebuchet MS';color:#333333;"><span style="font-size:78%;"><span style="color:#ffffff;">_</span> </span><br /></span></b><span lang="EN-GB" style="font-family:'Trebuchet MS';"><a href="http://www.mhra.gov.uk/home/groups/comms-sp/documents/publication/con041519.pdf"><span style="font-size:78%;">http://www.mhra.gov.uk/home/groups/comms-sp/documents/publication/con041519.pdf</span></a><u><o:p></o:p></u></span></p>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-5506807566550878126.post-16874008495771317402009-06-20T19:34:00.011+01:002009-07-06T11:51:34.957+01:00MHRA: Medicines and Healthcare products Regulatory Agency<p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span lang="EN-GB"><span style="font-family:trebuchet ms;color:#ffffff;">_</span></span></b></p><span style="mso-ansi-language: EN; mso-bidi-: EN-US" lang="EN"><span style="font-family:trebuchet ms;"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#000000;"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" >“<u>Medicines and Healthcare products Regulatory Agency: </u></span></b><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#000000;"><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" >An executive agency of the Department of Health</span></u></b><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';color:#666666;" lang="EN-GB" >We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.</span></b><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';color:black;" lang="EN-GB" >“</span></b></span><span style="font-family:'Trebuchet MS';"><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';color:white;" lang="EN-GB" ><span style="font-size:78%;">_<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p><span style="font-size:78%;"></span></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >“<u>Who we are</u></span></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA is an executive agency of the Department of Health.</span></span><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:black;" lang="EN" >”</span><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';color:black;" lang="EN" >“</span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >About us</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';color:black;" lang="EN" ><strong><span style="font-family:'Trebuchet MS';"><o:p><span style="color:#333333;">About us section</span></o:p></span></strong></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#333333;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#333333;">The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. <o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; COLOR: #333333; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#333333;">No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. <o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; COLOR: #333333; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#333333;">We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. <o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; COLOR: #333333; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#333333;">We aim to make as much information as possible publicly available. <o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; COLOR: #333333; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#333333;">We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public. <o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; COLOR: black; mso-list: l7 level1 lfo1; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';color:#333333;" lang="EN" ><span style="color:#333333;">We encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.</span></span><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';" lang="EN" ><span style="color:#000000;">”<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';color:#555555;" lang="EN" ><a href="http://www.mhra.gov.uk/Aboutus/index.htm"><span style="color:purple;"><span style="font-size:78%;">http://www.mhra.gov.uk/Aboutus/index.htm</span></span></a></span><span style="mso-ansi-language: EN;font-family:'Trebuchet MS';color:#333333;" lang="EN" ><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" >”</span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Our mission and values</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA's mission and values</span>.</span><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:place st="on"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" >Mission</span></b></st1:place><br /></span><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;"><span style="color:#333333;">The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe</span>.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;">Values<br /></span><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">In pursuing our mission we will strive to act with:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">integrity;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">openness;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">courtesy;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">responsiveness;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">timeliness;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">professionalism;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">impartiality; and<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l8 level1 lfo2; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">consistency.</span><span style="color:#000000;">”</span></span><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></b></li></ul><p style="MARGIN: 0cm 0cm 0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whoweare/Ourmissionandvalues/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whoweare/Ourmissionandvalues/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;color:#ffffff;">_</span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<br /></span><span style="color:#000000;"><span style="font-size:100%;">"</span></span></span></span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Our aims and objectives</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#333333;"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" >The MHRA's aims and objectives.</span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="color:#ffffff;">_</span></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ></span><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;">Aims</span></span></b><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><br /><span style="color:#ffffff;">_</span></span></b></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">Our aims are:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l6 level1 lfo3; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="color:#333333;"><strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Protecting public health</span></strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" > through regulation, with acceptable benefit-risk profiles for medicines and devices.<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l6 level1 lfo3; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="color:#333333;"><strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Promoting public health</span></strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" > by helping people who use these products to understand their risks and benefits.<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l6 level1 lfo3; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="color:#333333;"><strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Improving public health</span></strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" > by encouraging and facilitating developments in products that will benefit people.<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;">Objectives</span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;"><span style="color:#ffffff;">_</span><br /></span></span></b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">Our strategic objectives are to</span><span style="color:#333333;">:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo4; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="color:#333333;"><strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >safeguard public health</span></strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" > through our primary role in ensuring that the products we regulate meet required standards, that they work and are acceptably safe;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo4; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">carry out our <strong><span style="font-family:Arial;">communication</span></strong> role through the provision of accurate, timely and authoritative <strong><span style="font-family:Arial;">information</span></strong> to healthcare professionals, patients and the public;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo4; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">support <strong><span style="font-family:Arial;">research</span></strong>, ensuring through the application of <strong><span style="font-family:Arial;">Better Regulation</span></strong> principles that regulation does not stifle <strong><span style="font-family:Arial;">innovation</span></strong>;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo4; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">influence the shape of the future regulatory framework through use of our effective <strong><span style="font-family:Arial;">European and International</span></strong> relationships;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l0 level1 lfo4; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">run an <strong><span style="font-family:Arial;">organisation</span></strong> with a skilled and equipped workforce that is <strong><span style="font-family:Arial;">fit for the future</span></strong>.</span><span style="color:#000000;">"<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whoweare/Ouraimsandobjectives/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whoweare/Ouraimsandobjectives/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_</span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:100%;color:#000000;">"</span></span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >Our activities</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA's activities.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><strong><span style="color:#333333;">Our main activities are:<o:p></o:p></span></strong></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the <st1:country-region st="on"><st1:place st="on">UK</st1:place></st1:country-region> for human use;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">overseeing the UK Notified Bodies that audit medical device manufacturers;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating a proactive compliance programme for medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">regulating clinical trials of medicines and medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">promoting good practice in the safe use of medicines and medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">offering scientific, technical and regulatory advice on medicines and medical devices; and<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l3 level1 lfo5; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">providing the public and professions with authoritative information to enable informed dialogue on treatment choices.<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">These activities are supported by our ten divisions who are also responsible for: information management; providing executive support services; human resources; and finance.</span><span style="color:#000000;">"<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whoweare/Ouractivities/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whoweare/Ouractivities/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_</span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#000000;">"</span></span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >What we regulate</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering</span>.<span style="color:#000000;">"</span></span><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whatweregulate/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whatweregulate/index.htm</span></a><o:p></o:p></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_</span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#000000;">"</span></span></b><b style="mso-bidi-font-weight: normal"><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >What we regulate: Medicines</span></u></b><b style="mso-bidi-font-weight: normal"><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">Whether it’s a medicine you buy, or one prescribed for you as part of a course of treatment, it’s reassuring to know that all medicines available in the <st1:country-region st="on"><st1:place st="on">UK</st1:place></st1:country-region> are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.<o:p></o:p></span></span></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="color:#333333;"><strong>But what is, and is not, a medicine?<o:p></o:p></strong></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says. Claims that a product “supports” health or a healthy lifestyle is not usually considered as medicinal.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for.</span><span style="color:#000000;">"<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><a href="http://www.mhra.gov.uk/Aboutus/Whatweregulate/Medicines/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Whatweregulate/Medicines/index.htm</span></a><o:p></o:p></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="font-size:78%;"><span style="color:#ffffff;">_</span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><span style="color:#000000;"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" >"</span><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" >How we regulate</span></u></span><u><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><o:p></o:p></span></u></strong></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b style="mso-bidi-font-weight: normal"><span style="mso-ansi-language: EN-GB;font-family:'Trebuchet MS';" lang="EN-GB" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;"><strong>How we regulate section</strong>.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering. This section helps describe how the MHRA manages each of these products, including the use of nanotechnology in some of them.</span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:85%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The main difference between how medicines and medical devices are regulated lies in how a product gets onto the market. All medicines are directly approved by the MHRA which issues a 'marketing authorisation', or licence. Manufacturers and distributors are also licensed directly by MHRA. Medical devices are approved by private sector organisations called 'Notified bodies'. Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA. The MHRA audits the performance of Notified Bodies. However:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l1 level1 lfo6; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">when a product is on the market and in use, there are more similarities than differences in the ways medicines and devices are regulated<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l1 level1 lfo6; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">there are similar systems for receiving reports of problems with products and similar ways of issuing warnings if problems are confirmed after investigation<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l1 level1 lfo6; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">there are also similar systems for inspection of manufacture to ensure that companies are complying with regulations, and similar ways of enforcing the law if that proves necessary.<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;"><span style="font-size:85%;">Further information on how we regulate medicines and medical devices is available in our publication:</span><br /></span><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;">› </span><strong><span style="FONT-FAMILY: 'Trebuchet MS'; TEXT-DECORATION: none; text-underline: nonefont-family:Arial;color:#0a3296;" ><span style="font-size:78%;">'Medicines & Medical Devices Regulation: What you need to know'</span></span></strong><span style="TEXT-DECORATION: none; text-underline: nonecolor:#0a3296;" ><?xml:namespace prefix = v ns = "urn:schemas-microsoft-com:vml" /><v:shapetype id="_x0000_t75" preferrelative="t" spt="75" path="m@4@5l@4@11@9@11@9@5xe" filled="f" stroked="f"><span style="font-size:78%;"> </span></v:shapetype></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;">How we make regulatory decisions about medicines and medical devices<br /></span><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA and other related organisations make a lot of regulatory decisions. After consulting with a range of stakeholders we have set out on five pages the main considerations that affect those decisions:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l5 level1 lfo7; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><a href="http://www.mhra.gov.uk/Howweregulate/Howwemakeregulatorydecisionsaboutmedicinesandmedicaldevices/index.htm"><span style="color:#800080;">the role of MHRA and the scope of the document</span></a> <o:p></o:p></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l5 level1 lfo7; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><a href="http://www.mhra.gov.uk/Howweregulate/Whatkindsofdecisionsaremadeaboutmedicinesandmedicaldevices/index.htm"><span style="color:#800080;">the main regulatory decisions that are made about medicines and medical devices</span></a> <o:p></o:p></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l5 level1 lfo7; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><a href="http://www.mhra.gov.uk/Howweregulate/Whatprinciplesinformthedecisions/index.htm">the principles that inform these decisions</a> <o:p></o:p></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l5 level1 lfo7; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><a href="http://www.mhra.gov.uk/Howweregulate/Whatquestionsshouldbeconsideredtoensurethatreasonabledecisionsaremade/index.htm">the questions that are considered to ensure that the decisions are reasonable</a> <o:p></o:p></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l5 level1 lfo7; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><a href="http://www.mhra.gov.uk/Howweregulate/Whomakesthedecisions/index.htm">who makes decisions about medicines and medical devices – which includes bodies other than MHRA.</a> <o:p></o:p></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:85%;">A download version of the document is also available:<br /></span><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;">› </span><strong><span style="FONT-FAMILY: 'Trebuchet MS'; TEXT-DECORATION: none; text-underline: nonefont-family:Arial;color:#0a3296;" ><span style="font-size:78%;">Making Regulatory Decisions about Medicines and Medical Devices<span style="color:#000000;">"</span></span></span></strong></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="font-size:78%;"><a href="http://www.mhra.gov.uk/Howweregulate/index.htm">http://www.mhra.gov.uk/Howweregulate/index.htm</a></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_</span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><strong><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#000000;">"</span></span><u><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#000000;">Our structure<span style="color:#555555;"><o:p></o:p></span></span></span></u></strong></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="LINE-HEIGHT: 15.6pt; MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The MHRA' s main activities (below) are supported by our ten Divisions who are also responsible for: information management; providing executive support services; human resources; and finance.<o:p></o:p></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><!-- SS_END_SNIPPET(fragment6,splash_page_intro)--><!--SS_BEGIN_ELEMENT(region1_element3)--><!--SS_END_ELEMENT(region1_element3)--><!-- SS_BEGIN_SNIPPET(fragment9,splashpagebody)--><!-- call include to dynamically insert alt attributes into image tags within a wysiwyg element --><!-- get a reference to the wysiwyg content --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><!-- parse hyperlinked images --><!-- parse word documents --><!-- parse powerpoint documents --><!-- parse excel documents --><!-- parse pdf documents --><!-- parse links to the site --><!-- remove all hardlinks to cms --><!-- replace /stellent/ with current webroot --><span style="font-size:78%;"><span style="color:#ffffff;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;"><strong>The MHRA's activities:<o:p></o:p></strong></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the <st1:country-region st="on"><st1:place st="on">UK</st1:place></st1:country-region> for human use;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">overseeing the UK Notified Bodies that audit medical device manufacturers;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating a proactive compliance programme for medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">regulating clinical trials of medicines and medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">promoting good practice in the safe use of medicines and medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">offering scientific, technical and regulatory advice on medicines and medical devices; and<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l2 level1 lfo8; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">providing the public and professions with authoritative information to enable informed dialogue on treatment choices.<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><b><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#333333;" lang="EN" ><span style="color:#333333;">Corporate governance<o:p></o:p></span></span></b></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#ffffff;"><span style="font-size:78%;">_<o:p></o:p></span></span></span></p><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><span style="color:#333333;">The following structures and processes are designed to ensure accountability and give the Agency a framework for risk management:<o:p></o:p></span></span></p><ul type="disc"><li style="MARGIN: 0cm 0cm 0pt; mso-list: l4 level1 lfo9; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">The Agency Board is made up of a non-executive Chairman, six non-executive members and the Agency's Chief Executive Officer.<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l4 level1 lfo9; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">The Agency's Chief Executive is responsible for service delivery and resources.<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l4 level1 lfo9; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">The Executive Board, consisting of the Agency's directors, takes overall responsibility for day-to-day management, strategic decision-making, line management, and all financial, policy, operational and resource management issues.<o:p></o:p></span></span></li><li style="MARGIN: 0cm 0cm 0pt; mso-list: l4 level1 lfo9; tab-stops: list 36.0pt; mso-margin-top-alt: auto; mso-margin-bottom-alt: autocolor:#555555;" class="MsoNormal" ><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;" lang="EN" ><span style="color:#333333;">The Risk and Audit Committee provides independent feedback to the Chief Executive, who is also the Accounting Officer, and the Management Board on the effectiveness of our risk management processes. The Committee is supported by the Agency's Risk Management Team.</span><span style="color:#000000;">"<o:p></o:p></span></span></li></ul><p style="MARGIN: 0cm 0cm 0pt" class="MsoNormal"><span style="FONT-FAMILY: 'Trebuchet MS'; mso-ansi-language: ENfont-family:Arial;color:#555555;" lang="EN" ><a href="http://www.mhra.gov.uk/Aboutus/Ourstructure/index.htm"><span style="font-size:78%;color:#800080;">http://www.mhra.gov.uk/Aboutus/Ourstructure/index.htm</span></a><o:p></o:p></span></p></o:p></span></span>Unknownnoreply@blogger.com0