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A Practical Guide to Producing and Maintaining the PSMF Training Course

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

29 Jun 2021

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Course overview

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.

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

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

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, as well as the audit group.


Introduction, welcome and objectives

Introduction and background to the PSMF

  • The DDPS and the PSMF
  • Objectives of the PSMF
  • Registration of the PSMF
  • Regulatory requirements and accessibility of the PSMF
  • Responsibilities of the marketing authorisation holder, 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

Final discussion session


Graeme Ladds (More...)

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

Book now

Book now

29 Jun 2021
Live webinar
29 Jun 2021
Live webinar
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now

to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • APL Swift Services (Malta) Ltd
  • Athlone Laboratories
  • Consilient Health
  • DADA Consultancy BV
  • DBV Technologies
  • Del Corno & Associati s.a.s
  • Eisai Europe Limited
  • Ferrer Internacional, S.A.
  • Focus Care Pharmaceuticals B.V.
  • GBT
  • Gilead Sciences International Ltd
  • GW Pharmaceuticals
  • H. Lundbeck A/S
  • Iggea Ltd
  • Incyte Biosciences
  • JensonR+ Ltd
  • Mundipharma Research GmbH & Co Kg
  • Nelsons & Co Ltd.
  • Norgine
  • P&G Health Germany GmbH
  • Procter & Gamble
  • Pure Drug Safety Ltd
  • Real Regulatory Ltd
  • Recordati S.p.A
  • Rosemont Pharmaceuticals
  • Via Monte Rosa 10
  • Yes Pharma Services GmbH

I thought the whole presentation was very well laid out and the speed of the session was great. I learned a lot more than I thought. Greatly appreciated the addition of the Brexit topic.

Karen Jacobs, Senior Director, GBT, Jan 21

It was really good and enjoyable, it was a comfortable environment too.

Shelley Browning, Regulatory and PV Manager, Weleda, Jan 21

Great course. The content was relevant and covered everything I felt was necessary. Would highly recommend to colleagues.

Leah Baker, Senior Pharmacovigilance Scientist, Norgine, Jan 21

[The speaker] was open to questions, engaging and interactive. Also knowledgeable and touching on topics globally. The course was very insightful and brought upon many ideas to go forward and improve the PSMF when writing or creating one for different countries.

Nomie Butt, Product information and vigilance officer, Nelsons & Co Ltd., Jan 19

The course on the whole was very interesting and comprehensive, mainly due to the speaker's knowledge in the area.

Shayni Tharma, Head of Regulatory Affairs & Pharmacovigilance, Consilient Health Limited, Jan 19

It was a very useful and well-presented course, led by a very competent expert on the pharmacovigilance industry.

Thomas Stewart, Pharmacovigilance Officer, Consilient Health, Jan 19

The course provided a good insight into how the PSMF is managed across varying types of companies and the speaker reinforced the importance of the PSMF towards inspectors and the impact the global system has on the PSMF.

Sukhcharn Singh Sambhi, Pharmacovigilance Manager , Clovis Oncology, Jan 19

Clear and interesting with great knowledge.

Patricia Sraiki, Medical Safety Officer, Galapagos SASU, Jul 18

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, Jul 18

Very clear and speakers held the audience well.

Chrissa Cooper , Associate Director QPPV Office & PV Alliances , Norgine Ltd, Jan 18

Very clear, well organised, well presented, knowledgeable .

Nicolas Limbos, Safety expert, Keyrus Biopharma, Jan 18

Great, informative, very knowledgeable presenter.

Simon Ellis, European Qualified Person for Pharmacovigilance, Procter & Gamble, Jan 18

Good, valuable. Speaker was very knowledgable in PV.

Sue Chan, Safety Manager, Mitsubishi Tanabe Pharma Europe, Jan 18

An excellent, informative presentation with useful examples.

Helen Seurin, Senior Pharmacovigilance Officer, JensonR+ Ltd, Jul 16

Very good.

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies, Jul 16