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Management Forum

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.

★★★★★ "Excellent presenters and excellent presentations"

5 August 2024
+ 10 October 2024 »

from £549

Need help?  Enrol or reserve

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

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

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.

Enrol or reserve

The A Practical Guide to Producing and Maintaining the PSMF course will cover:

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

Enrol or reserve

Graeme Ladds
PharSafer Associates Ltd

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5 August 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13785

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 01 Jul

View basket 

Not ready to book yet?

for 7 days, no obligation

10 October 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13924

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 05 Sep

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's A Practical Guide to Producing and Maintaining the PSMF training course

In general, I was very satisfied with this webinar, I learned a lot.

Apr 24 2024

Jasmina Roca
QPPV deputy, Isdin

May 17 2023

Excellent presenters and excellent presentations

Irina Dukovska Teova
Pharmacovigilance specialist, Alkaloid AD Skopje

May 17 2023

Fantastic. Extraordinary experience, perfect communicator particularly for non-native English speakers. Very useful and practical examples to support the course content.

Ander Sologuren
Safety specialist – Clinical Pharmacovigilance, FAES FARMA SA

May 17 2023

I am very happy with the general content of this presentation, it covered everything which I wanted to know about the PSMF (and even more). The presentation was clear and the presenter had a lot of experience with the topic.

Giovanni Paffen
Officer Pharmacovigilance, Interdos Pharma

Jan 20 2023

Very knowledgeable speaker, easy to understand, perfect pace and clear explanations.

Jeanette Lerras
Lead GS Compliance Coordinator , Novo Nordisk A/S

Jan 20 2023

Well-presented and comprehensive overview of the PSMF. In-depth insight as to what to expect from CAs was appreciated. Speaker conveyed information in a clear and detailed manner.

Matthew Zarb
Pharmacovigilance Scientist & Responsible Person , Eugia Pharma (Malta) Ltd

Jul 12 2022

Excellent webinar and great speaker. Graeme was knowledgeable and experienced. He is very practical and explain questions in detail.

Swaminathan Velayutham
Quality Manager, Almus Pharmaceuticals Limited

Jul 12 2022

All of it- was very informative. It was 10/10.

Ellie Sutcliffe
PV Administrator/Associate, Rosemont Pharmaceuticals

Jan 20 2022

Very well explained and plenty of helpful examples

Laura Peralta Gámez
GCP&GVP QA , Ferrer Internacional

Jan 20 2022

Very well explained and plenty of helpful examples

Laura Peralta Gámez
GCP&GVP QA , Ferrer Internacional

Jan 20 2022

Graeme was an excellent presenter and I have made countless notes from the presentation and from the advice he shared with us on the course. I really enjoyed it and it was a great introduction for me into the PSMF so thank you :-)

Mark Lorenz
Operations Associate, Reckitt

Jan 20 2022

detailed overview and task-oriented tips

Irene Boz
Drug Safety Officer, Alliance Healthcare Management Services Ltd.

Jan 20 2022

The webinar was very informative and Graeme is a great speaker and he explained everything so well.

Preet Ekta Rai
Pharmacovigilance Specialist, Paladin Labs Inc

Jan 20 2022

Great webinar - content, presentation and speaker wise! Speaker has fantastic knowledge on Global PV requirements!

Minesh Vaidya
Head of Regulatory Compliance/RP/RPi/LSO/NCP, Nordic Pharma Ltd.

Jul 12 2022

Graeme was an excellent speaker, he is very knowledgeable and the information will be very useful.

Aimee Wright

Jun 29 2021

In depth information delivered clearly from an expert with masses of experience in the field.

Marketa Slee
Pharmacovigilance Specialist , SOTIO a.s.

Jan 29 2021

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 29 2021

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

Shelley Browning
Regulatory and PV Manager, Weleda

Jun 29 2021

Greame was clear and concise and answered our questions and gave good examples from his experience. Very enjoyable webinar with lots of content and clearly a very experienced speaker!

Claire Norman
Safety Advisor, The Boots Company

Jun 29 2021

Very clear explanation.

Gaetano Aiello
Manager, EU/International PV Office, JazzPharmaceuticals

Jun 29 2021

I hoped to better understand the content of the PSMF and what is requested during inspections. I definitely think that now I have a deeper insight on that and an overall comprehension of the best solutions to manage the PSMF properly. Very well presented, with a good level of details.

Giulia Ferrari

Jan 29 2021

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 29 2019

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 29 2019

[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 29 2019

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 29 2019

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 30 2018

Good, valuable. Speaker was very knowledgable in PV.

Sue Chan
Safety Manager, Mitsubishi Tanabe Pharma Europe

Jan 30 2018

Great, informative, very knowledgeable presenter.

Simon Ellis
European Qualified Person for Pharmacovigilance, Procter & Gamble

Jul 5 2018

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 5 2018

Clear and interesting with great knowledge.

Patricia Sraiki
Medical Safety Officer, Galapagos SASU

Jan 30 2018

Very clear, well organised, well presented, knowledgeable .

Nicolas Limbos
Safety expert, Keyrus Biopharma

Jan 30 2018

Very clear and speakers held the audience well.

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

Jul 5 2016

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

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

Jul 5 2016

Very good.

Yusouf Bah
Drug Safety and Pharmacovigilance Manager, DBV Technologies

Jul 5 2016

An excellent, informative presentation with useful examples.

Helen Seurin
Senior Pharmacovigilance Officer, JensonR+ Ltd

Jul 5 2016

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

Payal Patel

Jul 5 2016

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

United Kingdom

  • A Nelson & Co Ltd
  • Allergan
  • Alliance Healthcare
  • Alliance Healthcare Management Services Ltd.
  • Almus Pharmaceuticals Limited
  • Besins Healthcare
  • Clovis Oncology
  • Consilient Health
  • Consilient Health Limited
  • Doncaster Pharamceuticals Group Ltd.
  • Eisai Europe Limited
  • Ewopharma International s.r.o.
  • Fresenius Kabi AB
  • Fresenius Kabi Ltd & Calea UK Ltd
  • Gilead Sciences
  • Gilead Sciences International Ltd
  • GW Pharmaceuticals
  • hameln pharma ltd
  • JensonR+ Ltd
  • Mitsubishi Tanabe Pharma Europe
  • Nelsons & Co Ltd.
  • Nordic Pharma Ltd.
  • Norgine
  • Norgine Ltd
  • Orion Clinical Services Ltd
  • Panacea Pharma Projects Ltd
  • Pharmacosmos UK
  • Pharmacovigilance Matters Limited
  • Procter & Gamble
  • Pure Drug Safety
  • Reckitt
  • Rosemont Pharmaceuticals
  • The Boots Company
  • Veeva
  • Veterinary Medicines Directorate
  • Weleda


  • Alfa Wassermann S.p.A.
  • Alfasigma Spa
  • Angelini Pharma s.p.a.
  • Chiesi Farmaceutici SPA
  • Del Corno & Associati s.a.s
  • Gentium S.r.l
  • JazzPharmaceuticals
  • Proge Medica SRL
  • Recordati S.p.A
  • Via Monte Rosa 10


  • Asphalion
  • Chemo Research S.L.
  • Eignapharma
  • Ferrer Interancional, S.A.
  • Ferrer Internacional
  • Grupo Ferrer International
  • Isdin
  • Norgine
  • Pharma Mar, S.A.
  • PharmaMar


  • Laboratoires SMB s.a.
  • Bausch & Lomb Pharma nv
  • Conforma NV
  • Galapagos
  • Keyrus Biopharma
  • Therabel International Services
  • Zoetis
  • Zoetis Belgium S.A.


  • Boehringer Ingelheim Vetmedica GmbH
  • Cheplapharm Arzneimittel GmbH
  • Mundipharma Research GmbH & Co Kg
  • Mylan Healthcare GmbH
  • Otsuka Pharmaceutical Development & Commercialisation Europe GmbH
  • Otsuka Pharmaceutical Development and Commercialisation Europe GmbH
  • P&G Health Germany GmbH
  • Yes Pharma Services GmbH


  • 2care4 Generics ApS
  • H. Lundbeck A/S
  • Novo Nordisk A/S
  • Orifarm Group A/S
  • Pharmalex


  • AnticipSante SAS
  • DBV Technologies
  • Galapagos SASU


  • DADA Consultancy BV
  • Focus Care Pharmaceuticals B.V.
  • Interchemie werken "De Adelaar" B.V
  • Interdos Pharma
  • myTomorrows


  • Alkaloid-INT
  • Billev Pharma East
  • Medis d.o.o.


  • Alnylam Switzerland GmbH
  • Incyte Biosciences
  • Swedish Orphan Biovitrum AG

United States of America

  • EQRx
  • GBT
  • Global Blood Therapeutics


  • Athlone Laboratories
  • Real Regulatory Ltd


  • APL Swift Services (Malta) Ltd
  • Eugia Pharma (Malta) Ltd

Slovak Republic

  • Ewopharma International s.r.o
  • Ewopharma International, s.r.o.


  • Iggea Ltd


  • Paladin Labs Inc


  • Delorbis Pharmaceuticals Ltd

Czech Republic

  • SOTIO a.s.

Korea, Democratic People's Republic Of

  • Archigen Biotech Limited


  • AS Kalceks


  • Balkan Pharmaceuticals

North Macedonia

  • Alkaloid AD Skopje


  • Tecnimede Group


  • Unimedic Pharma AB

Enrol or reserve

Run A Practical Guide to Producing and Maintaining the PSMF Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749