A Practical Guide to Producing and Maintaining the PSMF

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

28 Jan 2020

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

All EU regulatory pharmacovigilance inspections start with the assessment of the pharmacovigilance system master file (PSMF). The PSMF provides the regulators with not only a detailed assessment of the system, but the outputs from that system contained in the Annexes provide an understanding of a company’s compliance. This course will provide a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

By attending this course you will:

  • Understand the regulatory requirements for the PSMF
  • Gain an overview of the key issues in producing, maintaining and updating the PSMF
  • Learn about the roles of the QPPV and the PSMF
  • Discuss the PSMF and regulatory inspections

Please note that we are also running:

Book together and save

This meeting runs back-to-back with Writing Risk Management Plans (RMPs). Save an additional £100/€140 if you book both courses.

To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend

This course will be relevant for anyone working in pharmacovigilance who requires a comprehensive overview of the PSMF, including QPPVs and those responsible for safety assessments. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, sales and marketing, legal, commercial and quality.


Introduction and background to the PSMF

  • Objectives of the PSMF
  • Registration of the PSMF
  • Regulatory requirements and accessibility of the PSMF
  • Responsibilities of the MAH, updates and the EU QPPV

The content of the PSMF

  • The PSMF template
  • The level of detail required by the PSMF
  • Preparation of the Annexes
  • The PSMF log book

The sections of the PSMF

  • The EU QPPV
  • Sources of safety data
  • IT and databases
  • Regulatory timeline compliance
  • The PSMF processes
  • The PSMF and audits
  • The company quality system and the PSMF

The Annex requirements for the PSMF

  • The company product list
  • The EU QPPV list of delegated tasks
  • The list of SOPs and procedures
  • List of delegated activities to third-party partners
  • A list of completed audits and schedules
  • A list of performance indicators for the PSMF section
  • The roles and responsibilities of the EU QPPV
  • Master file number and version changes (audit trail)

The PSMF and inspections

  • The PSMF and inspection findings
  • Regulatory authority requests to view the PSMF
  • Transfer of responsibility for a pharmacovigilance system to the QPPV
  • Notifying the QPPV of changes to the PSMF
  • PSMF responsibilities with shared marketing authorisation holders
  • Change control, logbook, versions and archiving
  • Audit trails and the PSMF
  • The PSMF post-inspection

Book now

28 Jan 2020
28 Jan 2020 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Alfa Wassermann S.p.A.
  • American Express Global Business Travel Espana
  • Athlone Laboratories
  • Balkan Pharmaceuticals
  • Boots UK Ltd
  • Chemo Research S.L.
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici SPA
  • Clovis Oncology
  • Consilient Health
  • DADA Consultancy BV
  • Del Corno & Associati s.a.s
  • Eisai Europe Limited
  • Ewopharma International s.r.o
  • Ferrer Internacional, S.A.
  • Gentium S.r.l
  • Gilead Sciences International Ltd
  • H. Lundbeck A/S
  • Iggea Ltd
  • Mitsubishi Tanabe Pharma Europe
  • Mundipharma Research GmbH & Co Kg
  • Mylan Healthcare GmbH
  • Norgine Ltd
  • Orion Clinical Services Ltd
  • Pharmacovigilance Matters Limited
  • Procter & Gamble
  • Recordati S.p.A
  • Rosemont Pharmaceuticals

Tons of experience. Very knowledgeable. Interesting, fun speaker, good stories that are easy to relate to.

Jill Brogaard, Senior PV Associate, H. Lundbeck A/S

Clear and interesting with a big knowledge

Patricia Sraiki, Medical Safety Officer, Galapagos SASU

Very clear, well organised, well presented, knowledgeable

Nicolas Limbos, Safety expert, Keyrus Biopharma

Great, informative, very knowledgeable presenter.

Simon Ellis, European Qualified Person for Pharmacovigilance, Procter & Gamble

Good, valuable. Speaker was very knowledgable in PV.

Su Chan, Senior Safety Officer, Mitsubishi Tanabe Pharma Europe

Very clear and speakers held the audience well

Chrissa Cooper , Associate Director QPPV Office & PV Alliances , Norgine Ltd

I found Graeme to be a very knowledgeable and accomplished speaker. His delivery and explanations were clear, and his depth of experience impressive. I would give Graeme 5 out of 5 for content and presentation skills.

Jacqueline Moss, Safety Specialist II, Gilead Sciences International Ltd

An excellent, informative presentation with useful examples.

Helen Seurin, Senior Pharmacovigilance Officer, JensonR+ Ltd

A complete course, content covered all the main topics, clear presentation hold by a brilliant speaker.

Roberta Valenti, Head of Corporate QA R&D , Recordati S.p.A

Approached really well to give an understanding to a member such as myself who isn't involved in the PSMF creation

Payal Patel, , Allergan

Very good

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies