RMP and PSUR in life-cycle management: An art, not a miracle

This seminar provides insights in particular into RMP and PSUR preparation, assessment and regulatory management.
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After completing the online seminar, you will
#be 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 and
#have a good understanding of the planning, preparation and management of additional risk minimisation measures.
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Insights into the global management of pharmacovigilance documents round off this seminar.

Themen

- Role of RMP and PSUR and life cycle alignment
- 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 measures