The concept of risk management in the context of Clinical Research has existed for quite some years and various guidelines have been published, like the EMA ‘Reflection paper on risk-based quality management in clinical trials’ 2013. Risk-based management in clinical trials focuses on identifying the most important risks in a trial and setting them as a priority in order to prevent and avoid potential disruption.

During this event, you will hear 3 presentations that will discuss concrete examples and applications
of risk-based approaches within data management, statistical programming and
statistics in the setting of clinical research.

Preliminary Program

09:30

Welcome

09:35

RBQM in CDM Getting ready for targeted querying?

by Peter Stokman (business lead RAVEN, Clinical Data Management), Bayer, Berlin

10:05

Risk-based statistical programming QC at Danone/Nutricia

by Paul Vervuren (Principal Statistical Programmer) and Gertjan van Maaren (Team Leader Statistical Programming), Danone, Utrecht

10:35

Using central monitoring to detect data fabrication in multicenter clinical trials

by Rutger van den Bor (assist. professor in Biostatistics, Julius Center) UMCU, Utrecht

11:00

Panel discussion with speakers

Registration

This event is free of charge. To register, please fill out the registration form here You will receive details by email on how to connect to our virtual event.