返回 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