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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
- Managing Director
- Wise PV&RM Ltd, United Kingdom
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
Speaker(s)
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
Practical Example of a Global Risk Management System
Paul Sheehan, MS
- Vice President, Global Risk Management
- Celgene Corporation, United States
REMS Compliance Program
Haley H Seymour, MS
- Consumer Safety Officer, OSI, OC, CDER
- FDA, United States
Global Risk Management
Kiernan Trevett, MSc
- Expert Pharmacovigilance Inspector
- Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
A Global Perspective of Risk Management
Claudia Manzo, PharmD
- Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
- FDA, United States
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Pharmacovigilance and Risk Management Planning
Short Course 2: Interdisciplinary Safety Evaluation During Product Development
Short Course 3: Reference Safety Information
Short Course 4: Introduction to Statistics in Pharmacovigilance
Short Course 5: Pharmacovigilance for Medication Errors
On Demand Content Preview Webinar
Preparing for PV Inspections – Beyond the Basics
Download eBook
Pharmacovigilance and Risk Management in 2020: A Global Perspective