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The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys
Session Chair(s)
Albin Karimattam, JD, PharmD
Associate Director, US Safety Risk Management
Novartis Pharmaceuticals Corporation, United States
Single shared system risk evaluation and mitigation strategies (REMS) are increasing in frequency with varying degrees of complexity. This session presents different perspectives to investigate its benefits & challenges to the different stakeholders. Physician knowledge surveys (EU) are increasingly requested of drug manufacturers. The session will focus on how best to design surveys to reliably measure physician awareness of safety.
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
FDA, United States
Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
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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