A Practical Guide to Producing and Maintaining the PSMF & Annexes Training Course

This course provides a practical guide to both producing and maintaining the PSMF to ensure Regulatory compliance and has been fully revised to include the latest updates.

16 September 2026 »
from £649

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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. We will discuss the processes and systems required to manage the PSMF as well as the latest advice on the impact of Brexit.

The course will also cover the role of the EU QP PV and Quality Assurance (QA) in the evolution of the PSMF and the internal audit aspects that ensure it is running efficiently and compliantly.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand the full scope of the regulatory requirements for the PSMF, enabling you to confidently meet compliance expectations
Gain a clear and practical overview of the key issues involved in producing, maintaining, and updating the PSMF, helping you streamline your approach
Discuss the PSMF as a QMS document and explore how it integrates within your wider quality management system
Learn about the roles of the QPPV and the PSMF, clarifying responsibilities and strengthening accountability across your organisation
Review common inspection findings and deficiencies related to the PSMF, so you can proactively address gaps and strengthen inspection readiness

Who should attend

This course is ideal for anyone working in pharmacovigilance who requires a comprehensive overview of the PSMF, including:

PVQAs
QPPVs
Those responsible for safety assessments

It will also be highly relevant for professionals who work closely with pharmacovigilance, including those in:

Regulatory affairs
Clinical
Sales and marketing
Legal
Commercial
Quality
Audit (PVQA)

This broad coverage ensures a shared understanding of PSMF requirements across functions, supporting stronger collaboration, compliance, and inspection readiness.

Popular with...

This course has proven particularly popular among our customers in these roles:

Drug Safety Officer
EU QPPV
Global PV Specialist
Pharmacovigilance Manager
Pharmacovigilance Officer
Pharmacovigilance Specialist
Senior Pharmacovigilance Scientist

Enrol/reserve

This course will cover:

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 (PVQA)
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 incl KPIs
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/reserve

Graeme Ladds
PharSafer Associates Ltd

Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.

Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug–device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.

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

16 September 2026

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 16381

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 12 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

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* 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.