Presented by
Management Forum

An Essential Overview of Pharmacovigilance

A practical guide to understanding the role of pharmacovigilance.

8 Apr 2022 + 1 more date

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

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.

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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The An Essential Overview of Pharmacovigilance 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

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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 An Essential Overview of Pharmacovigilance Live online training

8 Apr 2022

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 11607

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

Until 04 Mar

In your basket 

10 Oct 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11740

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

Until 05 Sep

In your basket 

Reviews of IPI's An Essential Overview of Pharmacovigilance training course


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.

Apr 26 2021

Shelley Browning
Regulatory and PV Manager, Weleda

Apr 26 2021

Very informative. Good content.

Anna-Faye Halls
Pharmacovigilance Coordinator, GW Pharmaceuticals

Apr 26 2021

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

Nicholas Gurreri
Safety scientist, GSK

Apr 26 2021

[The speaker was] very professional and knowledgeable.

Priyanka Parasher
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
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
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
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
Sr. RA Officer, Patheon Softgels, B.V.

Oct 12 2018

Brilliant course for beginner to understanding the world of PV.

Josephine Wong
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
Compliance Manager, Ceuta Healthcare

Oct 5 2017

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

Bonnie Allen
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
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
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
Regulatory Affairs officer , Porton Biopharma Limited

Apr 27 2017

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

Francesca Guarino
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
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
Pharmacovigilance, Quality & Safety and Global Regulatory Affairs Coordinator, Jazz Pharmaceuticals

Apr 27 2017

Very useful, comprehensive training and experienced speaker

Marion Autour
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
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
Regulatory specialist, clinical operations, Actavis UK Ltd

Oct 3 2016

The speaker was nice, friendly, approachable

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

UK

  • AbbVie
  • Actavis UK Ltd
  • Besins Healthcare
  • Biofrontera (UK)
  • Ceuta Healthcare
  • Chemidex Pharma Ltd - Egham
  • Chemidex Pharma Ltd.
  • Chiesi UK Ltd
  • Datapharm
  • Fresenius Kabi Ltd.
  • GSK
  • GW Pharmaceuticals
  • Holland & Barrett International Limited
  • Jazz Pharmaceuticals
  • Meda Pharmaceuticals Limited
  • Mundipharma Research Ltd
  • Nelsons
  • Nutrition Group Plc
  • Pharmacosmos
  • Pharmacosmos UK
  • Porton Biopharma Limited
  • RB Corporate Services Ltd
  • Reckitt Benckiser Brands Ltd
  • Servier Research & Development Ltd
  • Teva
  • Teva UK
  • Warner Chilcott (UK) Ltd
  • Weleda
  • Wortley Byers Law

Netherlands

  • Basic Pharma Manufacturing BV
  • Impatients N.V. tradename myTomorrows
  • Patheon Softgels, B.V.

Denmark

  • Novo Nordisk A/S
  • Pharma Nord ApS

Germany

  • Abbott Laboratories GmbH
  • CHEPLAPHARM Arzneimittel GmbH

Switzerland

  • Actelion Pharmaceuticals Ltd
  • F. Hoffmann-La Roche Ltd

Belgium

  • Emdoka bvba

Cyprus

  • Delorbis Pharmaceuticals Ltd

Estonia

  • Acino Estonia OÜ

Finland

  • MAP Medical Technologies Oy

France

  • Merial SAS

Italy

  • Chiesi Farmaceutici

Kuwait

  • Central medical stores

Latvia

  • AS Kalceks

Romania

  • Ewopharma AG

Russia

  • Roche Moscow Ltd.

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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