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Session 2: What's New at ICH and CIOMS?
Session Chair(s)
William Gregory, PHD
Senior Director, Safety and Risk Management, Pfizer Inc, United States
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
This session will include descriptions of new pharmacovigilance projects being undertaken by ICH and CIOMS including Selective Safety Data Collection, Patient Engagement, MedDRA Term Groupings, and Post-Marketing Safety Data Collection.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the overall approach to safety data collection being considered by the ICH E19 EWG
- Outline the key objectives of the CIOMS WG 11 Patient Engagement work group
- Describe potential value of principles for MedDRA Term Groupings in Reference Safety Information
- Understand why a revision to the ICH E2D guideline is needed
Speaker(s)
Speaker
Senior Director, Safety and Risk Management, Pfizer Inc, United States
Speaker
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
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