Hilton Baltimore Inner Harbor

Jan 27, 2025 7:30 AM - Jan 29, 2025 12:45 PM

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 3: Advancing PV: Industry Perspectives on FDA Updates, Risk Management, Data Standards, and Regulatory Alignment

Session Chair(s)

Sorcha  McCrohan, MS

Sorcha McCrohan, MS

Scientific Project Manager

DIA, United States

Mariette  Boerstoel-Streefland, MD, MBA, MS

Mariette Boerstoel-Streefland, MD, MBA, MS

Senior Vice President, Worldwide Patient Safety Officer

Bristol-Myers Squibb Company, 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  • Explain the purpose of FDA’s draft guidance and describe the three phases of the REMS logic model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)

Lubna  Merchant, PharmD, MS

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

Susan  Kindig, JD, MD

Updates on the FAERS Public Dashboard and ICH E2B(R3) Implementation

Susan Kindig, JD, MD

United States

Prior Executive Director, Medical and Drug Safety

Tarek  Hammad, MD, PhD, MS, MSc, FISPE

Achieving Synchrony: Bridging the Gap between Pharmaceutical Companies and Regulators on Safety Labeling Updates

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Takeda, United States

Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera

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