Pharmaceutical Executive Europe - March 2008 - (Page 22) 22 Event Review March 2008 Pharmaceutical Executive Europe is the ability of the sponsor to achieve life cycle control of all submissions, including instant recall of what was submitted when and to whom. While listening to these talks, I could not help but think that most companies have missed a grand opportunity to revise the way they perform their day-to-day work and have, instead, created yet another incremental process and system to serve the demands of the regulator. … the Association should continue to identify the most relevant and timely issues and opportunities facing the industry and actively push speakers to focus their presentations on them rather than on ‘tried and true’ topics. countries and territories ill equipped to fight back. Under the assumption that standards and methods of care will always vary by country or culture, it is inappropriate to think that ethics deemed correct in one place will be correct in another. Based on this input, I am now forced to rethink my own convictions about individual and corporate ethics. On a more practical front, Ms Christiane Druml of the Medical University Vienna, Austria, reviewed the widely varying practices of ethics committees (EC) within European countries. Ultimately, she wonders whether a centralised approach to the ethical review and approval of clinical trials would work better than the current decentralised method. We can expect the ‘jury’ to be out on this one for many more years. Final thoughts If I were looking for a single negative thing to say about this year’s EuroMeeting programme, it would have to do with the complement of topics within a specific session. In particular, there were too many sessions where the three presentations simply did not go together. This left me wondering about the impression of audience members who, based on the law of averages, would be interested in one topic, less interested in the second and totally uninterested about the third. Hopefully, the conference organisers will try to correct this in coming years. I hope now that DIA will adopt the theme and session method for the US annual meeting later this year and beyond. In conjunction with that, I would encourage the meeting planners to make sure that the typical three presentations within a session are indeed related. If possible, the Association should continue to identify the most relevant and timely issues and opportunities facing the industry and actively push speakers to focus their presentations on them rather than on ‘tried and true’ topics. Last but not least, the association should strive to further break down the barriers between distinct geographies (for example, US vs Europe vs Japan vs China) while recognising that there are operating and regulatory differences between them. This would potentially mean that the annual meetings be planned as a joint exercise between DIA USA and Europe. ■ Pharmacovigilance. One of the most exciting sessions, “Managing Signals Globally, Territorially and Locally” was chaired by June Raine of MHRA UK. Manfred Hauben of Pfizer discussed the variety of methods that can be used for signal detection and evaluation including PRR, ROR, BCPNN and MGPS. The use of these and other algorithms over time has convinced Dr Hauben that competing algorithms (including those used for data mining) will overall give you similar results. It is perhaps more important to focus on the tools and techniques that allow you to draw valid conclusions from the results such as drill down and data visualisation. In the same session, Andrew Bate of the Uppsala Monitoring Centre, Sweden, described the use of data mining methods utilising encounter-based patient data for signal detection. In this case, the data were collected in the UK and managed in a data warehouse by IMS. The bottom line from this talk is that patient data will increasingly become an important component of adverse event detection and evaluation. On a side note, the management of such a database by a for-profit company like IMS calls into question the potentially ill-advised moves by politicians, governments and consumer groups to prevent such companies from selling encounter-based data. Ethics. Ian Kerridge of the University of Sydney, Australia, chaired a session on “Ethical standards in clinical research: Challenges with internationalisation.” Perhaps the most thought provoking concept presented by Dr Kerridge was that of “ethical imperialism.” As you can guess, this means the imposition of your own ethics on About the Author George Laszlo is the managing director of Laszlo Consulting (US), a firm providing strategic IT consulting to the industry. He is also the editor of The Laszlo Letter, an online webzine devoted to operational excellence in life sciences via IT enablement. http://laszloletter.typepad.com/
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - March 2008 Pharmaceutical Executive Europe - March 2008 Contents From the Editor News and Analysis Brussels Report Calendar The Next Wave of Pharma Talent The New World Order Share of Voice to Share of Care Notes on a Meeting The Malta Story Motivation Across Borders The Mix No GUTs, No Global Green is Good Last Word Pharmaceutical Executive Europe - March 2008 Pharmaceutical Executive Europe - March 2008 - Pharmaceutical Executive Europe - March 2008 (Page 1) Pharmaceutical Executive Europe - March 2008 - Pharmaceutical Executive Europe - March 2008 (Page 2) Pharmaceutical Executive Europe - March 2008 - Contents (Page 3) Pharmaceutical Executive Europe - March 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - March 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - March 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - March 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - March 2008 - Brussels Report (Page 8) Pharmaceutical Executive Europe - March 2008 - Brussels Report (Page 9) Pharmaceutical Executive Europe - March 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - March 2008 - Calendar (Page 11) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 12) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 13) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 14) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 15) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 16) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 17) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 18) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 19) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 20) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 21) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 22) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 23) Pharmaceutical Executive Europe - March 2008 - The Malta Story (Page 24) Pharmaceutical Executive Europe - March 2008 - The Malta Story (Page 25) Pharmaceutical Executive Europe - March 2008 - The Mix (Page 26) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 27) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 28) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 29) Pharmaceutical Executive Europe - March 2008 - Last Word (Page 30)
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