RMP and PSUR in life-cycle management: An art, not a miracle - Insights into RMP and PSUR preparation, assessment and regulatory management

"This seminar provides insights in particular into RMP and PSUR preparation, assessment and regulatory management. After completing the online-seminar, you will: - become familiar with the pharmacovigilance requirements in the life cycle of a medicinal product; - understand how safety concerns evolve in the life cycle and impact RMPs and PSURs; - be able to handle EU assessment reports and understand their impact on RMPs and PSURs; - know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer; - be familiar with the tasks and duties of a QPPV in the life cycle of a marketing authorization; - have a good understanding of the planning, preparation and management of additional risk minimisation measures. Insights into the global management of pharmacovigilance documents round off this seminar. "