Joint MHRA/DIA Excellence in Pharmacovigilance

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

戻る Agenda

TOPIC 1: DEFINITIONS AND METHODS IN PHARMACOVIGILANCE

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

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)

Basic Definitions and Tools in Pharmacovigilance

Gaby L. Danan, MD, PHD

GLD, France

Pharmacovigilance Expert

Joint MHRA/DIA Excellence in Pharmacovigilance

TOPIC 1: DEFINITIONS AND METHODS IN PHARMACOVIGILANCE

Session Chair(s)

Gaby L. Danan, MD, PHD

Phil Tregunno

Speaker(s)

Basic Definitions and Tools in Pharmacovigilance

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