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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)
Reference Safety Information [RSI] and Management of Changes to RSI for Clinical Trials
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
Reference Safety Information [RSI] and Management of Changes to RSI for Clinical Trials
Esteban Herrero-Martinez, PhD
AbbVie, United Kingdom
Director Regulatory Policy and Intelligence
Management of GCP Breaches Under Clinical Trial Regulation - Sponsor's Perspective
Michael Smith
Merck Serono Ltd, United Kingdom
Quality Strategy Lead
Clinical Trials Safety Reporting [CTSR] - Status Update
Sophia Mylona
European Medicines Agency, Netherlands
Scientific Administrator, Compliance and Inspection
Panel Discussion with Q&A
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Panel Discussion with Q&A
Nektaria Varela
European Medicines Agency, Netherlands
Lead BA for EMA Technology and Architecture Business Analysis Service