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TOPIC 5 SESSION 2: An Overview of the Risk Management Process & the PRAC. The main components of the RMP
Session Chair(s)
Gaby L. Danan, MD, PHD
Pharmacovigilance Expert
GLD, France
Phil Tregunno
Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
In accordance with the GVP Module V on Risk Management System, risk management plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust epidemiological methods that will be described and examples discussed in this session. This session aims also to provide the background for understanding drug-related risks, and to present recent developments regarding risk communication.
Speaker(s)
An Overview of the Risk Management Process & the PRAC. The main components of the RMP
Julie Williams, PHD
MHRA, United Kingdom
Expert Assessor