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Session 11: A Global Perspective of Risk Management
Session Chair(s)
Lesley Wise, PHD, MSC
Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Jill K. Logan, PHARMD
Safety Evaluator, DPV I, OSE, CDER, FDA, United States
Balancing the benefits and risks of a drug can be challenging particularly when additional measures beyond product labeling are needed to communicate a risk or influence health care provider and patient behavior. This session seeks to highlight the similarities and differences in risk management strategies for drugs approved by multiple regulatory agencies, as well as differences in program implementation and assessment. An example will illustrate this global risk management strategy.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the differences between risk management strategies approved by various regulatory agencies
- Identify areas in which compliance differs between REMS and risk management plans
- Discuss risk management strategies that have achieved successful implementation in a complex global setting
Speaker(s)
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
Defining and Maintaining Global Company Risk Management Process
Paul Sheehan, MS
Vice President, Global Risk Management, Celgene Corporation, United States
Practical Example of a Global Risk Management System
Haley Seymour, MS
Consumer Safety Officer, OSI, OC, CDER, FDA, United States
REMS Compliance Program
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Global Risk Management
Claudia Manzo, PHARMD
Head of the Office of Risk Management, Pharmacovigilance and Patient Safety, AbbVie, United States
A Global Perspective of Risk Management