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Pharmacovigilance and Risk Management Strategies Conference

Session 11: A Global Perspective of Risk Management

Session Chair(s)

Lesley  Wise, PhD, MSc

Lesley Wise, PhD, MSc

  • Managing Director
  • Wise PV&RM Ltd, United Kingdom
Jill K. Logan, PharmD

Jill K. Logan, PharmD

  • Safety Evaluator, DPV I
  • Office of Surveillance and Epidemiology (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


Michael  Richardson, MD, FFPM

Defining and Maintaining Global Company Risk Management Process

Michael Richardson, MD, FFPM

  • International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
  • Bristol-Myers Squibb, United Kingdom
Paul  Sheehan, MS

Practical Example of a Global Risk Management System

Paul Sheehan, MS

  • Vice President, Global Risk Management
  • Celgene Corporation, United States
Haley H Seymour, MS

REMS Compliance Program

Haley H Seymour, MS

  • Consumer Safety Officer, OSI, OC, CDER
  • FDA, United States
Kiernan  Trevett, MSc

Global Risk Management

Kiernan Trevett, MSc

  • Expert Pharmacovigilance Inspector
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Claudia  Manzo, PharmD

A Global Perspective of Risk Management

Claudia Manzo, PharmD

  • Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
  • FDA, United States