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Session 11: Hot Topics
Session Chair(s)
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
This session will cover areas of drug safety which are problematic and require industry and regulators to work together in managing data in the post-approval space, in particular from multiple sources, both structured and unstructured data collection activities. Speakers will present on projects looking at what data can be of value to identifying signals and safety evaluation, how to manage real-world data such as the sentinel programs, and how best to utilize the specific risk management effectiveness evaluations through moving to a digital platform. Speakers will present on their topics then a joint panel for a Q&A will take place.
Speaker(s)
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
Digital Approach to Risk Minimization
Jeremy Jokinen, MS
Vice President Global Patient Safety, Argenx, United States
Value of Safety Information Data Sources
Peter Verdru, MD
Vice President, Head of Patient Safety, UCB Biopharma S.P.R.L., Belgium
Speaker
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Speaker
D. Tyler Coyle
Medical Officer, Food and Drug Administration, United States
Sentinel ARIA Process