RMP and PSUR in lifecycle management: An art, not a miracle - The advanced course in Risk Management
Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!
- The role of RMP and PSUR in the drug lifecycle
- Writing pharmacovigilance documents
- QPPV oversight
- Impact of EU assessment reports on RMPs and PSURs
- Effective global management and harmonisation of RMPs
and PSURs
- Additional risk minimisation measures
- If already published: GVP-Moduls XVI (Rev 3)
Veranstaltungs-Code | FB24-227620-56323550 |
Bildungsziel der Schulung:
This seminar deepens your knowledge in RMP and PSUR preparation, assessment and regulatory management.
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The update of GVP Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators is expected in summer 2024. The FORUM Institute and our speakers guarantee that we will incorporate all updates into the training in an understandable way!
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By attending this seminar, you will refresh your knowledge of the current European guidelines according to EMA Modules V and XVI. You will also learn new aspects of safety concerns and best practices for additional risk minimisation measures.
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Take a look at pharmacovigilance documents from a QPPV perspective and benefit from our speakers' many years of experience with global authorities or in writing and harmonising RMP and PSUR!
Veranstaltungsort:
Online-Webinar
Vollzeit
weitere Orte/Termine
Kursart:
Online-Webinar
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