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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)
Digital Approach to Risk Minimization
Mark Perrott, PhD
Axian Consulting Limited, United Kingdom
Value of Safety Information Data Sources
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
Speaker
Peter Verdru, MD
UCB Biopharma S.P.R.L., Belgium
Vice President, Head of Patient Safety
Speaker
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
Sentinel ARIA Process
D. Tyler Coyle
Food and Drug Administration, United States
Medical Officer