MEDICINES PHARMACOVIGILANCE AND REGULATORY ASPECTS
This course domain covers the Principles of pharmacovigilance, the Pharmacovigilance regulations and the Pharmacovigilance regulatory processes.
medicines, pharmacovigilance, regulatory aspects, regulation
- To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-authorisation environment and the roles of various stakeholders within pharmacovigilance.
- To develop an understanding of European, USA, Japanese and major local and worldwide regulations and guidelines concerning pharmacovigilance. Emphasis will be placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.
- To enable participants (specialists) to develop an understanding of the requirements of Pharmaceutical Industry of the operational aspects of pharmacovigilance as it relates to the preparation of documents legally required by regulatory bodies. Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.
Developed with the Regulatory expertise of the European Medicines Agency.
Developed with the Pharma Industry expertise of GlaxoSmithKline Research and Development Ltd, H. Lundbeck A/S, Novartis Pharma AG, Orion Corporation.