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Session 3: Advancing PV: Industry Perspectives on FDA Updates, Risk Management, Data Standards, and Regulatory Alignment
Session Chair(s)
Sorcha McCrohan, MS
Sr. Scientific Project Manager
DIA, United States
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer
Bristol Myers Squibb, United States
Pharmacovigilance is fundamental to safeguarding public health and relies on a comprehensive approach that includes effective risk management, accurate safety reporting, regulatory oversight, and collaboration across stakeholders. This session highlights recent advancements in these areas, beginning with a presentation on FDA updates including REMS integration with data standards, and a review of the FDA Guidance on the REMS Logic Model as a framework for linking program design with assessment. Attendees will gain insights on the FAERS public dashboard and the transition to the ICH E2B(R3) standard with a focus on the implications of these advancements for data quality, consistency, and FDA oversight. The final presentation will address the complexities of safety labeling updates while highlighting the responsibility of pharmaceutical companies, the oversight of regulatory agencies, and the challenges of achieving alignment across global stakeholders.
Learning Objective : - Identify advances in FDA pharmacovigilance and risk management strategies, including REMS
- Discuss the future vision of REMS integration with data standards, recent updates on REMS integration use cases and prototypes, and the significance of the REMS data standard publication
- Explain the purpose of FDA’s draft guidance and describe the three phases of the REMS logic model
Speaker(s)
Design and Implementation of Risk Minimization Measures Using REMS Logic Model – REMS Integration and Innovation
Lubna Merchant, PharmD, MS
AbbVie, United States
Head, Risk Management Strategy
Updates on the FAERS Public Dashboard and ICH E2B(R3) Implementation
Susan Kindig, JD, MD
United States
Prior Executive Director, Medical and Drug Safety
Achieving Synchrony: Bridging the Gap between Pharmaceutical Companies and Regulators on Safety Labeling Updates
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda Pharmaceuticals, United States
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV