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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.

30 Jun 2020

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 29 May

Book now

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
  • Learn about the roles of the QPPV and the PSMF
  • Discuss common inspection findings and deficiencies related to the PSMF

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, welcome and objectives

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

Final discussion session


Graeme Ladds

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

30 Jun 2020
30 Jun 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 29 May*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Laboratoires SMB s.a.
  • Alkaloid AD Skopje
  • Allergan
  • American Express Global Business Travel Espana
  • AnticipSanté SAS
  • Archigen Biotech Limited
  • Athlone Laboratories
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici SPA
  • Consilient Health
  • DADA Consultancy BV
  • Ewopharma International s.r.o
  • Ferrer Internacional, S.A.
  • Fresenius Kabi Ltd & Calea UK Ltd
  • Galapagos SASU
  • Gentium S.r.l. (Jazz Pharmaceuticals Company)
  • Gilead Sciences International Ltd
  • JensonR+ Ltd
  • Mundipharma Research GmbH & Co Kg
  • Nelsons & Co Ltd.
  • Norgine Ltd
  • Procter & Gamble
  • Pure Drug Safety Ltd
  • Recordati S.p.A
  • Research and Markets
  • Rosemont Pharmaceuticals
  • Yes Pharma Services GmbH
  • Zoetis Belgium S.A.

The course provided a good insight how the PSMF is managed across varying types 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

The course on a whole was very interesting and comprehensive, mainly due to the speakers knowledge in the area.

Shayni Tharma, Senior Regulatory Affairs and Pharmacovigilance Manager, Consilient Health Limited

[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.

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

Clear and interesting with a big knowledge

Patricia Sraiki, Medical Safety Officer, Galapagos SASU

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

Very clear, well organised, well presented, knowledgeable

Nicolas Limbos, Safety expert, Keyrus Biopharma

Good, valuable. Speaker was very knowledgable in PV.

Sue Chan, Safety Manager, Mitsubishi Tanabe Pharma Europe

Great, informative, very knowledgeable presenter.

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

Very clear and speakers held the audience well

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

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

Payal Patel, Allergan

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

Very good

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies

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