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Session 6: CTR – Safety Related Information Exchange
Session Chair(s)
Surendra Gokhale, DRSC, PHD
Senior Director, Global Regulatory Affairs and Capability Development Lead , F. Hoffmann-La Roche Ltd, Switzerland
This session will focus on the progress made on different elements of the safety reporting. This will include regulators and sponsors viewpoint on recently published Q&A from CTFG related to Reference Safety information [RSI], sponsors viewpoint on GCP breaches guidance draft published mid-2017 and need for further clarifications, and status update on Clinical Trials Safety reporting [CTSR] under CTR.
Speaker(s)
Elena Prokofyeva, MD, PHD, MPH
Head of Drug Safety Unit, Department of Research & Development, DG PRE, Federal Agency for Medicines and Health Products (FAMHP), Belgium
Reference Safety Information [RSI] and Management of Changes to RSI for Clinical Trials
Esteban Herrero-Martinez, PHD
Director Regulatory Policy and Intelligence, Novartis Pharmaceuticals UK Limited, United Kingdom
Reference Safety Information [RSI] and Management of Changes to RSI for Clinical Trials
Michael Smith
Quality Strategy Lead , Merck Serono Ltd, United Kingdom
Management of GCP Breaches Under Clinical Trial Regulation - Sponsor's Perspective
Sophia Mylona
Scientific Administrator, Compliance and Inspection, European Medicines Agency, Netherlands
Clinical Trials Safety Reporting [CTSR] - Status Update
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Panel Discussion with Q&A
Nektaria Varela
Lead BA for EMA Technology and Architecture Business Analysis Service, European Medicines Agency, Netherlands
Panel Discussion with Q&A
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