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An Essential Overview of Pharmacovigilance Training Course

A practical guide to understanding the role of pharmacovigilance.

★★★★★ "This was a very good course; interesting and relevant content, good presentation and very competent ... more (25)"

27 January 2025
+ 15 May 2025, 8-9 September 2025 »
from £649

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

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Course overview

Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. There are many requirements and duties for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non-compliance can be severe.

EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance, and this invaluable one-day course will help you meet that requirement with a concise overview of the pharmacovigilance function and current regulatory requirements.

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

Gain an overview of EU pharmacovigilance
Understand the documentation required by regulatory authorities
Clarify the roles and responsibilities of a licence holder
Understand the role of the Qualified Person for Pharmacovigilance (QPPV)
Review the standard operating procedures (SOPs) in relation to pharmacovigilance

Who should attend?

This course will be relevant for anyone requiring an overview of pharmacovigilance or wishing to consolidate existing knowledge. It will also benefit those working in pharmacovigilance, as well as those who support or interact with pharmacovigilance from areas including medical information, regulatory affairs, clinical, sales and marketing, legal, commercial and quality.

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This course will cover:

An introduction to EU pharmacovigilance

Safety report sources
Safety reporting requirements
Follow-up of safety reports
Electronic safety reporting
Safety file retention

Documentation to be supplied to regulatory authorities

Individual case safety reports – special situations – EU
Periodic safety update reports (PBRERs, DSURs, RMPs)
Answering queries from regulatory authorities
Updating product labelling – emphasis on safety changes

Department links in the company to pharmacovigilance

Product quality and pharmacovigilance
Sales and marketing and pharmacovigilance
Legal, commercial and pharmacovigilance
Regulatory and pharmacovigilance
Medical information and pharmacovigilance

The roles and responsibilities of a licence holder

Obtaining a licence for a product – the PSMF
Supporting the licence approval
Quality management requirements
Submissions and licence approvals
Regulatory inspections

The role of the QPPV

Essential attributes of the QPPV
The duties of the QPPV and what the QPPV must do
Internal audits of the company pharmacovigilance activities

SOPs in relation to pharmacovigilance

Why the need for SOPs?
Critical SOPs
SOP maintenance
SOP training
Who should be trained and in what?

Pharmacovigilance inspections

Purpose of a regulatory inspection
Scope of the pharmacovigilance inspection
Conduct of the pharmacovigilance inspection
The pharmacovigilance inspection report
Corrective actions following a pharmacovigilance inspection

Enrol/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

27 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 14462

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

Until 23 Dec

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

View basket

Not ready to book yet?

for 7 days, no obligation

15 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14692

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

Until 10 Apr

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

View basket

Not ready to book yet?

for 7 days, no obligation

8-9 September 2025

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14902

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

Until 04 Aug

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

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 An Essential Overview of Pharmacovigilance training course

This was a very good course; interesting and relevant content, good presentation and very competent speakers.

Jan 29 2024

Ellinor Eliasson Sweden
Senior Quality Consultant, Scandinavian Regulatory Services AB

Jan 29 2024

The content of the course was comprehensive and the speakers gave a good oral presentation.

Markus Wollenweber Switzerland
Owner, Wollenweber GMP/GDP-Services

Sep 11 2023

I refreshed my knowledge of Pharmacovigilance and learnt about changes in the industry. Excellent speaker, delivered in a clear and professional manner making it easy to follow and understand. Graeme came across in a relaxed manner, making the course more engaging.

Nicky Wightman United Kingdom
Pharmacovigilance Support, Boots Pharmaceuticals

Jan 31 2023

Very good and worthwhile course / training that I would recommend to others

Christopher Brend Netherlands
Global Quality Services Manager, Abbott Healthcare Products B.V

Apr 26 2021

It was brill for an overview! Questions were answered by the speaker and the atmosphere made me feel really comfortable and allowed me to ask the questions in a confident way.

Shelley Browning United Kingdom
Regulatory and PV Manager, Weleda

Apr 26 2021

Very informative. Good content.

Anna-Faye Halls United Kingdom
Pharmacovigilance Coordinator, GW Pharmaceuticals

Apr 26 2021

Graeme was knowledgeable on all the material. [Overall] very good and informative.

Nicholas Gurreri United Kingdom
Safety scientist, GSK

Apr 26 2021

[The speaker was] very professional and knowledgeable.

Priyanka Parasher United Kingdom
Global Pharmacovigilance and Product Information officer, Nelsons

Oct 11 2019

All round, a thoroughly enjoyable course which gave a broad overview of PV. The speaker was absolutely amazing and I particularly enjoyed the anecdotes he added from his previous experience.

Alice Brown United Kingdom
Pharmacovigilance Trainee, GW Pharmaceuticals

Oct 11 2019

The course provided a good overview of pharmacovigilance. Graeme made the course very interesting with lots of useful examples and I would definitely recommend this to other colleagues.

Sue Harper United Kingdom
PV Team Coordinator, GW Pharmaceuticals

Oct 11 2019

A clear and informative presentation. The speaker was very knowledgeable and delivered the course at a good pace. I particularly liked that [he] gave examples for each section of the topic.

Sio M Leong United Kingdom
Senior Associate Pharmacovigilance , GW Pharmaceuticals

Oct 11 2019

Overall, I was glad I could attend this course. A lot of practical examples were shared and all my questions were resolved.

Elena Ojeda Netherlands
Sr. RA Officer, Patheon Softgels, B.V.

Oct 12 2018

Brilliant course for beginner to understanding the world of PV.

Josephine Wong United Kingdom
Pharmacovigilance Coordinator, Chemidex Pharma Ltd.

Oct 12 2018

The content and Graeme's knowledge and examples were very good - his slides could have been updated to be more watchable. Great course, will recommend.

Sarah Freeman United Kingdom
Compliance Manager, Ceuta Healthcare

Oct 5 2017

Particularly enjoyed the examples which the speaker gave, it really aids understanding. Interesting content.

Bonnie Allen United Kingdom
Vigilance Risk Management Student Placement, Mundipharma Research Ltd

Oct 5 2017

Content was clear and simple to understand. Presentation was consistent and easy to follow + Graeme was cheerful and informative with the correct level of professionalism

Sophie Burden United Kingdom
Regulatory Affairs officer , Porton Biopharma Limited

Oct 5 2017

Very informative, liked that there were notes to take away for future reference. The speaker was great and went through the content in a way which engaged us.

Bonnie Allen United Kingdom
Vigilance Risk Management Student Placement, Mundipharma Research Ltd

Oct 5 2017

Content was clear and informative, the slides were interesting and provided clear information, and the speaker was brilliant

Sophie Burden United Kingdom
Regulatory Affairs officer , Porton Biopharma Limited

Apr 27 2017

Deep and comprehensive content. Engaging and prepared speaker. Clear presentation.

Francesca Guarino United Kingdom
Besins Healthcare

Apr 27 2017

No negatives what so ever - it is exactly as described - an essential overview - without being too information heavy.

Emma Ryan United Kingdom
PV Administrator, Chiesi UK Ltd

Apr 27 2017

The course was a very good overview of PV, it's responsibilities and how it fits into industry.

Chloe Harper-Ahston United Kingdom
Pharmacovigilance, Quality & Safety and Global Regulatory Affairs Coordinator, Jazz Pharmaceuticals

Apr 27 2017

Very useful, comprehensive training and experienced speaker

Marion Autour United Kingdom
Pharmacovigilance Manager, Servier Research & Development Ltd

Oct 3 2016

The course was good enough for 1 day. Content was condensed and informative. Good presentation .

Ghadir Alqallaf Kuwait
Pharmacist, Central medical stores

Oct 3 2016

I was very pleased that I choose to do this course. The content was very in-depth without being overwhelming. I found it useful to have the slides printed off as well as going through on screen as made it a lot easier to make notes and comments on. The speaker was very clear and helpful and made things easy to understand.

Kayleigh Sexon United Kingdom
Regulatory specialist, clinical operations, Actavis UK Ltd

Oct 3 2016

The speaker was nice, friendly, approachable

Zakiya Rahman United Kingdom
Regulatory Affairs & Deputy national safety officer, Fresenius Kabi Ltd.

United Kingdom