Vivid discussion at GQMA – GCP Working Group Meeting

Katja Neuer, Director Business Development at MLM and chair of the GQMA – Good Clinical Practice Working group, invited all members to MLM on Friday November 17th, for the third meeting this year.

With 22 attendees, from pharma companies, CROs and service providers, the meeting was well visited and very active.

After a short welcome and introduction of MLM by Katja Neuer, small reports from previous conferences followed. Annette Angenendt, Marketing Manager at MLM, updated the attendees with topics from the GQMA annual meeting in September and Ingo Rath and Petra Esfeld from CliPS gave a summary of the 5th QA Meeting in Edinburgh.

Silke Kern gave a very comprehensive overview of the “Guideline on GCP compliance in relation to trial master file 5 (paper and/or electronics) for content, management, archiving, audit and inspection of clinical trials (EMA/15975/2016)” and highlighted what has changed.

A topic that seems to be omnipresent in all areas these days was presented by Detlef Detgen from AMS: “Data protection in electronic media, e.g. patient apps”. Personal data in clinical trials are highly sensitive, but digitalization offers great chances so the responsibility for e.g. data monitors has grown and will grow in the future.

Another professional group that is facing new requirements are clinical monitors. Bettina Weise from AMS presented the different task areas a clinical monitor has and what challenges they are facing in their every day life, when working GCP compliant. Her talk started off a very vivid discussion about the question whether more guidelines/documentation really improve the quality or if we just produce more paperwork? The gap between aspiration and reality seems to become bigger and bigger.

The discussion probably would have gone on for much longer, but due to the timeframe it had to be shortened but will be handed in as a topic proposal for the next year annual GQMA congress.

Just in time Katja Neuer closed the 46. GCP working group meeting and sent everybody off to a hopefully nice weekend.