Presented by
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"
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
- Signal Detection and Regulatory Expectations
- A Practical Guide to Producing and Maintaining the PSMF
- A Practical Guide to Writing Risk Management Plans (RMPs)
- AI in Pharmacovigilance
- Additional Risk Minimization Measures (aRMMs) and Their Effectiveness
- Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP)
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.
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.
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.
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.
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
14 February 2025
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 14439
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 10 Jan
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
23 June 2025
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 14640
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 19 May
- 2 sessions of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
3 October 2025
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 14994
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 29 Aug
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
R & D Manager (Agricultural), EVANS VANODINE INTERNATIONAL PLC
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
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
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
- EVANS VANODINE INTERNATIONAL PLC
- 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
- Uptitude
- Veeva
- Veterinary Medicines Directorate
- Weleda
Italy
- 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
- ZAMBON SPA
Spain
- Asphalion
- Chemo Research S.L.
- Eignapharma
- FAES FARMA SA
- Ferrer Interancional, S.A.
- Ferrer Internacional
- Grupo Ferrer International
- Isdin
- Norgine
- Pharma Mar, S.A.
- PharmaMar
Belgium
- Laboratoires SMB s.a.
- Bausch & Lomb Pharma nv
- Conforma NV
- Galapagos
- Keyrus Biopharma
- MITHRA PHARMACEUTICALS
- MSD
- Therabel International Services
- Zoetis
- Zoetis Belgium S.A.
Germany
- 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
Denmark
- 2care4 Generics ApS
- H. Lundbeck A/S
- Novo Nordisk A/S
- Orifarm Group A/S
- Pharmalex
France
- AnticipSante SAS
- CEVA SANTE ANIMALE
- DBV Technologies
- Galapagos SASU
- INNATE PHARMA
Netherlands
- DADA Consultancy BV
- Focus Care Pharmaceuticals B.V.
- Interchemie werken "De Adelaar" B.V
- Interdos Pharma
- myTomorrows
Slovenia
- Alkaloid-INT
- Billev Pharma East
- Medis d.o.o.
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
Malta
- APL Swift Services (Malta) Ltd
- Eugia Pharma (Malta) Ltd
Portugal
- ALFASIGMA SPA
- Tecnimede Group
Slovak Republic
- Ewopharma International s.r.o
- Ewopharma International, s.r.o.
Bulgaria
- Iggea Ltd
Canada
- Paladin Labs Inc
Cyprus
- Delorbis Pharmaceuticals Ltd
Czech Republic
- SOTIO a.s.
Finland
- Woikoski Oy
Greece
- VIANEX SA
Korea, Democratic People's Republic Of
- Archigen Biotech Limited
Latvia
- AS Kalceks
Moldova
- Balkan Pharmaceuticals
North Macedonia
- Alkaloid AD Skopje
Sweden
- Unimedic Pharma AB
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:
