Cyntegrity was honored to be invited to the
X Interdisciplinary Drug Development Expert Workshop, which was organized by PPH plus and dedicated to burning topics of today’s pharma world, such as risk management in clinical trials, personalized (precision) medicine, eTMF, CRO oversight.
Dr. Klausmann started the event with the inspiring topic about the ideal protocol from the view of an investigator.
He summed up, how the modern protocols are often detached from reality, how hard it is to follow them with different groups of patients, especially, when a trial includes a number of amendments on its way.
Dr. Widler (Managing Partner of Widler & Schiemann Ltd.) continued with an energetic discussion about Risk-based Monitoring (RbM) and study management from the site’s point of view. This was an extraordinary presentation, full with simple-to-understand examples about RbM and its application involving clinical sites. Of course, this presentation was followed by a number of questions and even hot discussions from the audience among investigators and pharma-representatives.
After a vivid discussion of the first two presentations, Prof. Dr. Jochen Maas (General Manager, R&D Germany, Sanofi-Aventis Deutschland) opened the next session guiding the audience into an emerging world of personalized medicine. He showed that this field is still full of questions of scientific, ethical and even political nature.
Arthur Hecht (Quality Management – Medicine & Regulatory, Boehringer Ingelheim) made a forecast how the electronic Trial Master Files (TMF) of the future should look like.
Jens Opitz, Senior Director, Head Corporate Clinical Operations, Merz Pharmaceuticals, closed the event with an exciting discussion about CRO oversight strategies: Laissez-faire versus Micromanagement. Particularly this topic initiated a flow of exciting questions to the speaker.
As a result, the highlights of the event were as follows:
- A great choice of speakers.
- Very good team work, near-to-perfect organization.
A gripping moderation by Dr. Schenk and Dr. Klöpel.