RMP and PSUR in life-cycle management:
An art, not a miracle -
Seminar / Kurs
von FORUM Institut für Management GmbH
Insights into RMP and PSUR preparation, assessment and regulatory management
- RMP management in the post-authorisation phase - Insights in pharmacovigilance writing and QPPV oversight - Impact of EU assessment reports on RMPs and PSURs - Effective global management and harmonisation of RMPs
and PSURs - Additional risk minimisation measuresTips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
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.
This seminar is intended for those working in the pharmaceutical industry already having profound knowledge of pharmacovigilance writing (with a focus on PSUR and RMP). QPPVs and people responsible for national pharmacovigilance are also invited to join the intensive discussion.
Termine und Orte