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The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
320

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys

Chair(s):
Albin Karimattam, JD, PharmD
Associate Director, US Safety Risk Management
Novartis Pharmaceuticals Corporation, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Establishing and Managing Single Shared REMS Programs: A PMO Perspective on Challenges and Best Practices
Jemma Contreras, PhD
Director, Risk and Program Management
Campbell Alliance, United States

Single Shared System REMS: FDA Perspective
Claudia B. Manzo
Acting Director,Office of Medication Error Prevention & Risk Management, OSE
FDA, United States

Physician Knowledge Surveys as Part of Risk Minimization Plans and Pharmacovigilance
Alexander Liede, PhD, MSc
Observational Research Director
Amgen Inc., United States