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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
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)
Contributing Panelist:
Pieter Vankeerberghen
European Medicines Agency, Netherlands
Head of Clinical Trials
Contributing Panelist:
Judith Creba, PhD
Novartis Pharma AG, Switzerland
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
Contributing Panelist:
Ruediger Pankow, DrSc
Germany
Regulatory Affairs Expert, CTIS SME and PO
Contributing Panelist:
Kristof Bonnarens, MPharm
European Commission, Belgium
Policy Officer Pharmaceuticals
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