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.

29 Jan 2019

& 3 Jul 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 21 Dec

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) on 2 July 2019. 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 requiring 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.


09.00 Registration and Coffee

09.30 Meeting begins

Introduction and background to the PSMF

  • What is the role of the PSMF?
  • When to submit the PSMF
  • Subcontracting pharmacovigilance activities
  • Regulatory requirements for the PSMF
  • Responsibilities of the MAH

The content of the PSMF

  • The PSMF template
  • The detail in the PSMF
  • Preparation of the Annexes
  • The PSMF log book

The sections of the PSMF

  • Section on the EU QP PV
  • Sources of safety data
  • IT and databases
  • Regulatory timeline compliance
  • The PSMF processes
  • Testing of quality in the PSMF
  • The Company Quality System

The Annex requirements for the PSMF

  • The Company Product List
  • The EU QP PV 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 QP PV
  • 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

17.00 Meeting ends


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

29 Jan 2019
29 Jan 2019 Cavendish 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 21 Dec
Enrol now
3 Jul 2019
3 Jul 2019 Rembrandt Hotel, London 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.
  • Alkaloid AD Skopje
  • Allergan
  • American Express Global Business Travel Espana
  • Athlone Laboratories
  • Balkan Pharmaceuticals
  • Besins Healthcare
  • Boots UK Ltd
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici SPA
  • Conforma NV
  • Del Corno & Associati s.a.s
  • Ewopharma International s.r.o
  • Ferrer Internacional, S.A.
  • Galapagos SASU
  • H. Lundbeck A/S
  • Iggea Ltd
  • Incyte Biosciences
  • JensonR+ Ltd
  • Mitsubishi Tanabe Pharma Europe
  • Mundipharma Research GmbH & Co Kg
  • Norgine Ltd
  • Procter & Gamble
  • Proge Medica SRL
  • Real Regulatory Ltd
  • Recordati S.p.A
  • Unimedic Pharma AB
  • Yes Pharma Services GmbH

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

Great, informative, very knowledgeable presenter.

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

Very clear and speakers held the audience well

Chrissa Cooper , QPPV Office & PV Alliances Manager , Norgine Ltd

Good, valuable. Speaker was very knowledgable in PV.

Su Chan, Senior Safety Officer, Mitsubishi Tanabe Pharma Europe

Very clear, well organised, well presented, knowledgeable

Nicolas Limbos, Safety expert, Keyrus Biopharma

Very good

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies

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

An excellent, informative presentation with useful examples.

Helen Seurin, Senior Pharmacovigilance Officer, JensonR+ 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

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

Payal Patel, , Allergan