Pharmaceutical Executive Europe - March 2008 - (Page 21)
Pharmaceutical Executive Europe March 2008 Event Review 21 Notes on a Meeting George Laszlo outlines his personal IT highlights from the 2008 DIA EuroMeeting, held earlier this month in Barcelona and co-chaired by Truus Janse-de Hoog and Beat Widler [pictured]). s a veteran of many DIA annual meetings in the USA, I must admit that this year’s Euromeeting was like a breath of fresh air. A key reason was the calculated risk that the meeting planners took by redesigning the programme around themes and sessions, the highlights of which are below. A insisted on their use, Inglis would now be able to use whatever EDC system he felt like and do so regardless of study or sponsor. eCTD. Alison Davis of MHRA UK discussed the realities of moving a regulatory agency from a paper to electronic-based environment. As an agency working under the decentralised procedure (DP), she noted that MHRA has received very few eCTDs so far, even though they spent a lot of time and energy getting ready for them. She feels that the key reason for this is that most sponsors are focusing their eCTDs on the Centralised Procedure (CP) for obvious economic reasons. Geoff Williams of Roche Products UK discussed the transition that his company has made over the years creating electronic submissions and their interactions with regulatory agencies. A key learning from this talk was the need to think about such submissions not as the final milestone but the start of a serious dialogue between the sponsor and the regulator. Along these lines, a follow-on talk by Has van Bruggen of eCTD Consultancy, the Netherlands, stressed that the most important advantage of eCTDs EDC. Fraser Inglis, director of the Glasgow Memory Clinic, gave his reaction to the use of EDC from the investigative site point of view. I found this to be important since we rarely hear from these users. Inglis conveyed that after five years of increased use, his facility is now doing 100% of their trials with EDC. As an investigative site, his staff must contend with multiple EDC systems, all of them imposed by either the sponsor or the CRO. It was therefore natural for him to state that adequate training was the most important component of successful use. From my perspective, his situation sheds light on this most unfortunate consequence of EDC adoption: the proliferation of incompatible platforms. Had the industry focused on the development of data exchange standards earlier in the game and
Table of Contents 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
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