Professional Training
4.6 (31 Reviews)

A Practical Guide to Producing and Maintaining the PSMF

Length
1 day
Price
649 GBP 549 - 649 GBP
Next course start
5 August, 2024 (+5 start dates)
Course delivery
Virtual Classroom
Length
1 day
Price
649 GBP 549 - 649 GBP
Next course start
5 August, 2024 (+5 start dates)
Course delivery
Virtual Classroom
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A Practical Guide to Producing and Maintaining the PSMF

The pharmacovigilance system master file (PSMF) is a legal requirement for any medicinal product authorised in the European Union. The PSMF provides the regulators with a detailed description and assessment of the entire pharmacovigilance system and the outputs contained in the annexes provide an understanding of a company’s compliance. This course will provide a practical guide to planning, writing, maintaining and updating the PSMF to ensure compliance. The programme will cover the importance of the PSMF in regulatory inspections, including common PSMF inspection findings. You will discuss the processes and systems required to manage the PSMF as well as the latest advice on the impact of Brexit.

Upcoming start dates

Choose between 5 start dates

5 August, 2024

  • Virtual Classroom
  • Online
  • English

10 October, 2024

  • Virtual Classroom
  • Online
  • English

14 February, 2025

  • Virtual Classroom
  • Online
  • English

23 June, 2025

  • Virtual Classroom
  • Online
  • English

3 October, 2025

  • Virtual Classroom
  • Online
  • English

Suitability - Who should attend?

Benefits of attending

  • Understand the regulatory requirements for the PSMF
  • Gain an overview of the key issues in producing, maintaining and updating the PSMF
  • Discuss the PSMF as a QMS document
  • Learn about the roles of the QPPV and the PSMF
  • Review common inspection findings and deficiencies related to the PSMF

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Reviews by course attendees

Average rating 4.6

Based on 31 reviews.
Reviews are published according to our review policy.
Write a review!
5/5
Giovanni P
17 May 2023

I am very happy with the general content of this presentation, it covered everything which I wanted to know about the PSMF (and even more). The presentation was clear and the pr...

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5/5
Ander S
17 May 2023

Fantastic. Extraordinary experience, perfect communicator particularly for non-native English speakers. Very useful and practical examples to support the course content.

5/5
Irina D
17 May 2023

Excellent presenters and excellent presentations

International Professional & Industry Academy
10-12 Rivington Street
EC2A 3DU London

About IPI Academy

International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...

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