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Virtual

Nov 18, 2020 1:45 PM - Nov 19, 2020 7:00 PM

(Central Europe Standard Time)

Clinical Trial Regulation Conference

Session 3: Joint Session - Panel Discussion & Key Takeways of 5 years of CTR, Future Strategy, possible changes

Session Chair(s)

Nick  Sykes, MS

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)

Pieter  Vankeerberghen

Contributing Panelist:

Pieter Vankeerberghen

European Medicines Agency, Netherlands

Head of Clinical Trials

Judith  Creba, PhD

Contributing Panelist:

Judith Creba, PhD

Novartis Pharma AG, Switzerland

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU

Ruediger  Pankow, DrSc

Contributing Panelist:

Ruediger Pankow, DrSc

Independent Consultant, Germany

Clinical Regulatory Affairs Expert, CTIS SME

Kristof  Bonnarens, MPharm

Contributing Panelist:

Kristof Bonnarens, MPharm

European Commission, Belgium

Policy Officer Pharmaceuticals

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