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Holiday Inn London Kensington Forum

Sep 28, 2015 8:00 AM - Oct 02, 2015 1:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

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

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TOPIC 1: DEFINITIONS AND METHODS IN PHARMACOVIGILANCE

Session Chair(s)

Gaby L. Danan, MD, PHD

Gaby L. Danan, MD, PHD

Pharmacovigilance Expert, GLD, France

Phil Tregunno

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)

Gaby L. Danan, MD, PHD

Gaby L. Danan, MD, PHD

Pharmacovigilance Expert, GLD, France

Basic Definitions and Tools in Pharmacovigilance

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