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Session Chair(s)
Albin Karimattam, JD, PHARMD
Associate Director, US Safety Risk Management
Novartis Pharmaceuticals Corporation, United States
Learning Objective : Identify challenges in building single shared system risk evaluation and mitigation strategies (REMS) with multiple drug sponsors; Describe best practices in the design, execution, and monitoring of a single shared system; Discuss thinking around the objectives and pragmatic design for physician knowledge surveys as part of risk minimization plans.
Speaker(s)
Establishing and Managing Single Shared REMS Programs: A PMO Perspective on Challenges and Best Practices
Jemma Contreras, PHD
Campbell Alliance, United States
Director, Risk and Program Management
Single Shared System REMS: FDA Perspective
Claudia Manzo, PHARMD
AbbVie, United States
Head of the Office of Risk Management, Pharmacovigilance and Patient Safety
Physician Knowledge Surveys as Part of Risk Minimization Plans and Pharmacovigilance
Alexander Liede, PHD, MSC
Abbvie, Ireland
Senior Director, Global Epidemiology
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