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TOPIC 5: RISK MANAGEMENT
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)
Jan Petracek, MD, MSC
CEO, iVigee Services a.s., Czech Republic
Risk Communication in EU – Challenges and Possibilities
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