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 into RMP and PSUR preparation, assessment and regulatory management.
After completing the seminar, you will:
- be able to understand and handle your RMP correctly according to the current guidelines;
- be familiar with the tasks and duties of a QPPV in the lifecycle of a marketing authorisation;
- know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer;
- be able to handle EU assessment reports and understand their impact on RMPs and PSURs;
- 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.