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

& 2 Jul 2019

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

All EU regulatory pharmacovigilance Inspections start with the assessment of the 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 2017 update.

Topics to be covered include:

  • Production, maintaining and updating the PSMF
  • Maintaining the Annexes associated with the PSMF
  • Control of the PSMF including the EU QP PV and the XEVMPD
  • The PSMF and major changes
  • The PSMF audits and 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 4 July 2018 and also Risk Evaluation and Mitigation Strategies (REMS) on 6 July 2018. There is a further £100/€140 discount off each course when booked together.

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 requiring a comprehensive overview of the pharmacovigilance function and duties, particularly those who are responsible in pharmacovigilance for any safety assessments and writing such plans including any EU QP PVs who approve such documents. Those who work with pharmacovigilance, e.g. regulatory affairs, clinical, sales and marketing, legal, commercial and quality must sign off such documents.


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 Annexe 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 trial)

The PSMF and inspections

Requests for the PSMF

The PSMF and quality

Log books and audit trails

The PSMF post inspection


Graeme Ladds (29 Jan 2019)

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%
Enrol now
2 Jul 2019
2 Jul 2019 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • A Nelson & Co Ltd
  • Alkaloid AD Skopje
  • Allergan
  • American Express Global Business Travel Espana
  • Balkan Pharmaceuticals
  • Boots UK Ltd
  • Cheplapharm Arzneimittel GmbH
  • Chiesi Farmaceutici SPA
  • DBV Technologies
  • Del Corno & Associati s.a.s
  • Ewopharma International s.r.o
  • Ferrer Internacional, S.A.
  • Galapagos SASU
  • Gentium S.r.l
  • H. Lundbeck A/S
  • Iggea Ltd
  • Incyte Biosciences
  • Mitsubishi Tanabe Pharma Europe
  • Mundipharma Research GmbH & Co Kg
  • Mylan Healthcare GmbH
  • Norgine Ltd
  • Pharmacovigilance Matters Limited
  • Procter & Gamble
  • Proge Medica SRL
  • Pure Drug Safety Ltd
  • Real Regulatory Ltd
  • Recordati S.p.A
  • Unimedic Pharma AB

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

Great, informative, very knowledgeable presenter.

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

Very clear, well organised, well presented, knowledgeable

Nicolas Limbos, Safety expert, Keyrus Biopharma

An excellent, informative presentation with useful examples.

Helen Seurin, Senior Pharmacovigilance Officer, JensonR+ 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

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

Very good

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies

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