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Welcome and Session 2: Navigating FDA, EMA, and MHRA Regulatory Policy Shifts Updates to Stay Ahead of Compliance
Session Chair(s)
Sorcha McCrohan, MS
Sr. Scientific Project Manager, DIA, United States
Katie Truong
SVP & Managing Director, DIA Americas and Global Head of Business Operations, DIA, United States
Scott Janiczak, PHARMD, MPH
Team Leader, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
Stephanie Millican, PHD, MSC
Deputy Director Benefit Risk Evaluation, Safety and Surveillance, MHRA, United Kingdom
This session will provide updates from the Office of Surveillance and Epidemiology (OSE) within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) on the Office’s recent advances/initiatives in pharmacovigilance and risk management strategies. The session will also provide an overview of the strategic direction of the MHRA with a focus on developments in signal and benefit/risk assessment.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe recent FDA updates regarding pharmacovigilance and risk management strategies and assessing safety signals
- Explain the MHRA approach to assessment of signals and benefit risk evaluation and describe recent updates and strategic developments
Speaker(s)
Updates from the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Speaker
Head of Pharmacovigilance Office, European Medicines Agency, Netherlands
Updates on Key Regulatory Strategies from the MHRA
Head of Gastrointestinal system, Nutrition, Endocrine and Fertility, MHRA, United Kingdom
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