Pharmacovigilance System Master File (PSMF)

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)

2. 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

3. 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

4. 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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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.