Presented by
Management Forum

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 latest updates.

20 Jan 2022 + 3 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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

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.

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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

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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.

More details

Book A Practical Guide to Producing and Maintaining the PSMF Live online/Classroom training

20 Jan 2022

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11550

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 16 Dec

In your basket 

5 Apr 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11944

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 01 Mar

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

12 Jul 2022

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 11674

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 07 Jun

In your basket 

4 Oct 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11946

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 30 Aug

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

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


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

Jun 29 2021

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
PHARMACOVIGILANCE SPECIALIST, Angelini Pharma s.p.a.

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
Allergan

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

UK

  • A Nelson & Co Ltd
  • Allergan
  • Besins Healthcare
  • Clovis Oncology
  • Consilient Health
  • Consilient Health Limited
  • 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
  • JensonR+ Ltd
  • Mitsubishi Tanabe Pharma Europe
  • Nelsons & Co Ltd.
  • Norgine
  • Norgine Ltd
  • Orion Clinical Services Ltd
  • Panacea Pharma Projects Ltd
  • Pharmacovigilance Matters Limited
  • Procter & Gamble
  • Pure Drug Safety
  • Reckitt
  • Rosemont Pharmaceuticals
  • The Boots Company
  • Veterinary Medicines Directorate
  • Weleda

Italy

  • Alfa Wassermann S.p.A.
  • 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
  • ZAMBON SPA

Belgium

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

Germany

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

Spain

  • Chemo Research S.L.
  • FAES FARMA SA
  • Ferrer Interancional, S.A.
  • Grupo Ferrer International
  • Pharma Mar, S.A.
  • PharmaMar

France

  • AnticipSante SAS
  • CEVA SANTE ANIMALE
  • DBV Technologies
  • Galapagos SASU
  • INNATE PHARMA

Netherlands

  • DADA Consultancy BV
  • Focus Care Pharmaceuticals B.V.
  • myTomorrows

Switzerland

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

United States of America

  • EQRx
  • GBT
  • Global Blood Therapeutics

Ireland

  • Athlone Laboratories
  • Real Regulatory Ltd

Slovak Republic

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

Slovenia

  • Alkaloid-INT
  • Medis d.o.o.

Bulgaria

  • Iggea Ltd

Czech Republic

  • SOTIO a.s.

Denmark

  • H. Lundbeck A/S

Korea, Democratic People's Republic Of

  • Archigen Biotech Limited

Latvia

  • AS Kalceks

Macedonia, The Former Yugoslav Republic Of

  • Alkaloid AD Skopje

Malta

  • APL Swift Services (Malta) Ltd

Moldova

  • Balkan Pharmaceuticals

Sweden

  • Unimedic Pharma AB

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Multiple colleagues?
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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy