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Session 3: Adapting Risk Minimization Strategies Across the Product Lifecycle
Session Chair(s)
Balmeet Gurm, MD
Executive Director, Therapeutic Area Lead Cardiovascular and EBs, Patient Safety
Bristol Myers Squibb, United States
Jamie Wilkins, PharmD
Head, Risk Management Center of Excellence
Pfizer Inc, United States
Journey of Risk Mitigation from decision-making for core risk management strategies, to lifecycle management and modifications as safety profiles evolve and effectiveness is evaluation, through programmatic elimination.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe best practices for setting core risk minimization approach
- Identify approaches for modification to risk minimization programs when new data is available
- Define various approaches and rationales for eliminating additional risk minimization measures and REMS programs
Speaker(s)
Risk Management Evolution: The Eliquis ARMM Decommissioning Story
Kinjal Patel
Bristol Myers Squibb, United States
Patient Safety Scientist
CAMZYOS REMS Data Support of Label Update
Dewey Seto
Bristol Myers Squibb, United States
Director, REMS Strategy
Removal of CAR T REMS
Liza Rodriguez, MPH
Bristol Myers Squibb, United States
AD, Global Risk Management, US REMS Strategy and Submission Program Lead
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