This Module is part of the MHRA/DIA Excellence in Pharmacovigilance training course

Module 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.