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Session 2: Implementation of EU Clinical Trial Regulation
Session Chair(s)
Mette Stockner, MD
Senior Pharmacovigilance Director
Savara ApS, Denmark
The Clinical Trial Regulation EU 536/2014 is set out to optimise the clinical trial processes running across Europe. This will have a major impact on Member States, Ethics Committees and companies/MAHs when it comes to safety reporting. Are you ready for the implementation of the EU-CTR? Have you reviewed your current processes, systems and organisation for the clinical trial applications and safety reporting? This session will provide a status of the implementation on the regulatory side and give some insights from the company/MAH perspective on the practicalities with the implementation and what the changes means for the organisation.
Speaker(s)
Challenges and practical issue: implementing CTFG RSI requirements at Novo Nordisk A/S
Britt Joergensen
Novo Nordisk A/S, Denmark
Safety Surveillance Principal Specialist
Safety in clinical trials under the Clinical Trial Regulation: Major Challenges
Elena Prokofyeva, MD, PhD, MPH
Federal Agency for Medicines and Health Products (FAMHP), Belgium
Head of Drug Safety Unit, Department of Research & Development, DG PRE
Challenges and Practical Issues with the EU-CTR implementation from a Company point of view
Barbara Reinhardt
Merck Healthcare KGaA, Germany
Associate Director | Global Patient Safety | Safety Science
Clinical Trial safety reporting in the new Regulation 536/2014
Massimiliano Sarra, PhD, MPH
Italian Medicine Agency (AIFA), Italy
Permanent official and CTFG Secretary