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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 1: DEFINITIONS AND METHODS IN PHARMACOVIGILANCE. SESSION 1: Basic Definitions and Tools in Pharmacovigilance

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

Topic 1 will provide a concise overview of the objectives and the scope of Pharmacovigilance. The development of key definitions based on Community legislation and consensus, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the CIOMS Working Groups will be summarised. Practical examples and exercises will be used to illustrate the key definitions in Pharmacovigilance and the methods used in Pharmacovigilance in order to detect signals. The Risk Management process will be described, including the main components of the Risk Management Plan.

Speaker(s)

Gaby L. Danan, MD, PhD

Basic Definitions and Tools in Pharmacovigilance

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France

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+41 61 225 51 51

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+41 61 225 51 55