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Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.


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

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France
Phil  Tregunno

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • 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)

Julie  Williams, PhD

An Overview of the Risk Management Process & the PRAC. The main components of the RMP

Julie Williams, PhD

  • Expert Assessor
  • MHRA, United Kingdom

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