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CIOMS IX: Practical Approaches to Risk Minimization and Its Evaluation
Session Chair(s)
William Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc, United States
Routine risk minimization applies to all medicinal products. However, in certain instances, additional risk minimization tools may be necessary to ensure that product benefits outweigh risks and the product remains available to patients. In these cases, it is important to appropriately characterize the risk and frame the goals for the non-routine interventions. These first steps are followed by selection of the least burdensome tool(s) that are implementable and, at the same time, will also achieve the desired goals under real-world conditions. Knowing which tools to use, how to measure their effectiveness, and when to make modifications are key to success. In this session, three members of the Council for International Organizations of Medical Sciences (CIOMS) IX Working Group will review concepts, practical considerations, and implications for the biopharmaceutical industry.
Learning Objective : Discuss implications of the CIOMS IX report in risk management; Translate practical knowledge of non-routine risk minimization interventions into risk management planning; Identify how to evaluate the effectiveness of risk minimization tools.
Speaker(s)
Practical Approaches to Selecting Nonroutine Tools for Risk Minimization
Stephen Heaton, MD
Bayer HealthCare Pharmaceuticals, Germany
Global Pharmacovigilance, Head of Center of Excellence Risk Management Sciences
Practical Approaches to Measuring Effectiveness
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Consultant, United Kingdom
Strategy
Practical Approach to Future Efficiencies in Risk Minimization
William Gregory, PhD
Pfizer Inc, United States
Senior Director, Safety and Risk Management