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Session 3: Joint Session - Panel Discussion & Key Takeways of 5 years of CTR, Future Strategy, possible changes
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
The Clinical Trials Regulation was finalised in 2014 but is to be implemented more than seven years later. During that time the design and conduct of clinical trials has evolved; complex innovative design trials have become more mainstream, use of digital technologies have shown the potential for great efficiencies in the running, monitoring and the collection of data without compromising the rights or safety of participants. This session will convene a panel of experts who will consider how the clinical trial ecosystem has evolved and will continue to evolve and how the provisions outlined in the Clinical Trials Regulation and the structures developed to support the implementation of the Regulation may need to be adapted to maintain Europe’s competitiveness as a location for clinical research.
Speaker(s)
Pieter Vankeerberghen
Head of Clinical Trials, European Medicines Agency, Netherlands
Contributing Panelist:
Judith Creba, PhD
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland
Contributing Panelist:
Ruediger Pankow, DRSc
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Contributing Panelist:
Kristof Bonnarens, MPharm
Policy Officer Pharmaceuticals, European Commission, Belgium
Contributing Panelist: