New
Certification
Pharmacovigilance System & QPPV Readiness (Team Package)
About this Course
Run a compliant PV system and prepare for PV inspections in the EU and MENA.
A team package: bought once by your company and used by every colleague who needs it, from 3 participants. Delivered as live virtual, workshop, assessment, with 6 modules and about 18 hours of training per participant.
See plans, the buying process and how to request a proposal on the Team Training Packages page.
What You Will Achieve
This package covers:
- GVP modules and the PV system master file
- Case processing, MedDRA coding and expedited reporting
- Signal management and risk management plans
- PSUR/PBRER preparation and timelines
- MENA requirements: SFDA, EDA, MOHAP and JFDA guidelines
- PV audits and inspection readiness
Target Audience
QPPV, local PV responsible persons, drug safety officers.
Bookable for teams: Team plan (3–9 participants), Department (10–24), Enterprise (25+) or In-house at your site.
Program Outline
| Module | Topic | Duration |
|---|---|---|
| 1 | GVP modules and the PV system master file | ~3 h |
| 2 | Case processing, MedDRA coding and expedited reporting | ~3 h |
| 3 | Signal management and risk management plans | ~3 h |
| 4 | PSUR/PBRER preparation and timelines | ~3 h |
| 5 | MENA requirements: SFDA, EDA, MOHAP and JFDA guidelines | ~3 h |
| 6 | PV audits and inspection readiness | ~3 h |
Registration Fee
Price on request
30-Day Money-Back Guarantee
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Start Date Dates to be announced
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Location Team Package
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Language English
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Certificate Official Certificate of Completion