José Ortiz will be participating as a trainer together with Marcela Fialova and Claire Longman, MSc Interim Head of GCP and Senior Pharmacovigilance Inspector at the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom in the Pharmacovigilance System Master File (PSMF) course organized by DIA. The training will be delivered online from 1:00 PM to 5:00 PM (CEST) on November 2 to 3, 2022.
This virtual live training course covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF).
This key document describes the company’s pharmacovigilance system, supporting, and documenting its compliance with the requirements laid down in the EU legislation and is the first document requested by a Competent Authority in preparation of a pharmacovigilance inspection.
The entire course is in line with the guidelines on EU Good Pharmacovigilance Practices (GVP): Module II – Pharmacovigilance System Master File (rev. 2), Commission Implementing Regulation (EU) No. 520/2012, and relevant EMA guidelines.
Participants benefit from hands-on expertise on best practices shared by trainer with extensive experience regarding PSMF including the EU-QPPV perspective. Ample time is set aside for Q&A and interactive discussions.
- (GVP) Module II – Pharmacovigilance System Master File (rev. 2) guidance
- Creation, maintenance, and management of the PSMF
- Drafting a PSMF
- The PSMF as a quality document
- Regulatory expectations for the PSMF
- PSMF after an inspection
Interested in joining?
The complete training information and program can be found at this link: