Pharmacovigilance System Master File (PSMF)

  • 1° EDITION: 6 December 2023
  • 2° EDITION: 24 May 2024
  • Online
  • Italian

Training overview

The Pharmacovigilance System Master File (PSMF) is the key tool for managing the corporate pharmacovigilance system and supporting oversight by the QPPV. The objective of the course is to present the relevant regulations and analyze the PSMF by examining its format, content, and how it is written, archived, and maintained. The course also includes an overview of the main deviations found during inspection.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • November 5th 2024
  • April 8th 2025

(*) Contact us via email or phone to enroll.

Interested in Pharmacovigilance training?

Key points of the training

  • Pharmacovigilance System Master File (PSMF) Regulatory Requirements
  • Understand the structure of the PSMF and know what information should be reported in it
  • Know which corporate departments are involved in drafting and/or retrieving the information to be included in the PSMF
  • How to implement and maintain an updated PSMF
  • Know the most common deviations found during pharmacovigilance inspections

09:00 – 13:00 COURSE SESSION

  1. Introduction

Regulatory bases:

  • Directive 2010/84/EU and EU Regulation 1235/2010.
  • The EU Implementing Regulation 520/2012
  • The Module II of the Good Pharmacovigilance Practice Guide
  • The Ministerial Decree of April 30, 2015
  • Objectives of the PSMF and key concepts for the management of all PSMF-related activities
  • Registration and Maintenance (Form 1.8.1, localization, data recording in XEVMPD,…)
  • Transfer of Responsibility (delegation of responsibilities/activities)
  1. Structure of the PSMF (CORE and Annexes).

Description of the content and form of the PSMF: the main body and annexes and presentation of practical examples

  1. Management of the PSMF
  • Management of updates and revisions
  • Interaction with other departments/partners for retrieval and transposition of information relevant to the PSMF
  • Accessibility and distribution
  1. Deviations most commonly encountered during inspections by Regulatory Authority.

Operators in pharmaceutical companies with knowledge of pharmacovigilance who are involved or will be involved in the implementation and/or maintenance of the PSMF. The course offers a general overview of all aspects of the PSMF, and provides some insights and practical examples regarding the implementation and maintenance of the document.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Adele Terrosi

Adele Terrosi

Team Leader Senior Drug Safety Officer

Pharma D&S

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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