Global Pharmacovigilance and Risk Management Strategies Conference

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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.

Refresher on risk minimization strategy decision-making and approach

Modification of risk minimization measures/REMS post study read-out utilizing updates for a CV drug: reduction in ECHO monitoring, learnings, implementation, and regulatory success

Removal/Elimination of aRMMs and REMS: use case for an anticoagulant product, and CAR-T therapies regulatory success, and approach to analysis

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

Patient Safety Scientist, Bristol Myers Squibb, United States

CAMZYOS REMS Data Support of Label Update

Director, REMS Strategy, Bristol Myers Squibb, United States

Removal of CAR T REMS

AD, REMS Strategy & Submissions, Patient Safety, Safety Evidence & Sciences, Bristol Myers Squibb, United States

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