Objectives: To enable participants (specialists) to develop an understanding of the requirements of the Pharmaceutical Industry’s operational aspects of pharmacovigilance as it relates to the preparation and assessment 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. Topics covered: Case reporting Periodic reporting Product Labelling and Risk Management Plans Contractual arrangements
Quality - GMP, GCP, GLP