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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)
Defining and Maintaining Global Company Risk Management Process
Michael Richardson, MD, FFPM, FRCP
Bristol-Myers Squibb, United Kingdom
Senior Vice President, WorldWide Patient Safety
Practical Example of a Global Risk Management System
Paul Sheehan, MS
Celgene Corporation, United States
Vice President, Global Risk Management
REMS Compliance Program
Haley Seymour, MS
FDA, United States
Consumer Safety Officer, OSI, OC, CDER
Global Risk Management
Kiernan Trevett, MSc
Roche, United States
Principal Quality Lead, PDQ Quality Assurance Process GVP
A Global Perspective of Risk Management
Claudia Manzo, PharmD
FDA, United States
Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
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