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Introduction to Veterinary Pharmacovigilance Training Course

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

18-19 Oct 2022

& 6-9 Feb 2023 , 29-30 Jun 2023 , 4-5 Oct 2023

Book or reserve now


Course Overview

This two-day event has been designed to provide an essential overview of veterinary pharmacovigilance and will offer practical guidance and basic training for all those working in drug safety in the EU.

Our experienced trainer will clarify roles and responsibilities, explain commonly used terminology and take participants through all the key aspects of this complex subject. There will be plenty of time for interaction and questions and answers to enable participants to get a good understanding of the issues involved. The use of industry case studies will demonstrate real-life scenarios to help embed learning.

Benefits of attending:

  • Gain an overview of the European regulatory framework
  • Understand the requirements of the new EU pharmacovigilance legislation
  • Learn about VICH
  • Understand adverse event reporting
  • Hear about causality assessment
  • Minimise the impact of data with errors
  • Get to grips with literature searches
  • Understand UK PV requirements post Brexit 

Who should attend?

The course will be beneficial to those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers, together with regulatory affairs and personnel from registration departments, will also find this seminar useful.


What is pharmacovigilance?

  • Beneficial and harmful effects of veterinary medicinal products
  • Key definitions

The current regulatory framework and its global impact

  • Overview of European regulatory framework, the EU pharmacovigilance legislation
  • Implications for global environment – link to VICH
  • Practical applications of definitions
  • Role of the MAH
  • Role of the NCA/EMA
  • Role of the QPPV

Adverse event reporting

  • Definitions
  • Impact of VICH guidelines
  • Expedited vs periodic
  • How to handle animal SARs
  • Handling human SARs
  • Understanding the wider scope of pharmacovigilance

Causality assessment

  • The principles of causality assessment with practical examples
  • Medical evaluation of individual reports of adverse events
  • Strategies for follow-up

Identifiable Reporter

Do vets report AEs and why?

Electronic communication in pharmacovigilance

  • Reporting in EV Vet

EV Vet demo

Minimising the impact of data with errors

  • Consistent assessment and coding

Clinical trial AE reporting requirements

  • Post-authorisation safety studies
  • Phase IV studies

Literature searches

  • Peer-reviewed worldwide literature
  • Local journals and magazines


  • VMD (UK), VDD (Canada) and APVMA (Australia) requirements
  • Format and content of the PSUR
  • Analysis of data
  • Incidence calculation
  • Compliance and the PSUR


Declan O'Rourke (More...)

Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.

He is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec PV Consultancy Ireland specialising in pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

He is Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School and Past President of British Cattle Veterinary Association.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at Reserve now
18-19 Oct 2022
Live webinar
UK (London)
18-19 Oct 2022
Live webinar
UK (London)
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 13 Sep*
Enrol now
to attend Live webinar
6-9 Feb 2023
Live webinar
UK (London)
6-9 Feb 2023
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 2 Jan 23*
Enrol now
to attend Live webinar
29-30 Jun 2023
Face-to-face, Rembrandt Hotel London
UK (London)
29-30 Jun 2023
Rembrandt Hotel London
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 25 May 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days 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
4-5 Oct 2023
Live webinar
UK (London)
4-5 Oct 2023
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 30 Aug 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Aqua Pharma Group
  • Avimedical BV
  • Beaphar BV
  • Boehringer Ingelheim
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Cyton Biosciences Ltd
  • Grovet BV
  • Huvepharma
  • Intervacc AB
  • Knowledgepool Group Limited
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd
  • Pharmacosmos
  • Pharmacovigilance Matters Limited
  • Pharmaq
  • Pharmaxim AB
  • Salfarm Danmark A/S
  • Scanvacc AS
  • Seacalx AS
  • SSCL Animal and Plant Health Agency
  • TBC
  • Versele-Laga
  • Vetcare Oy
  • Zoetis Deutschland GmbH

Well designed course that covers the process in the right amount of detail for different delegates, and was very interactive in getting delegates ideas and comments on areas. Presentation was simple and easy to follow given how much there was to cover, and was very well presented from Declan.

Liam Aylwin, Internal Audit Manager, Dechra Pharmaceuticals, Apr 22

Very informative and interesting webinar. Well explained by the speaker, who was very knowledgeable and experienced.

Aimee Wright, R & D Manager (Agricultural), EVANS VANODINE INTERNATIONAL PLC, Apr 21

I am pleased with the webinar. I feel like I learned a lot. For now I will try to get some real experience with writing PSUR and adverse events and then I would like to proceed with the advanced webinar on veterinary pharmacovigilance.

Natascha van Heugten-Cappelle, QPPV, Aesculaap BV, Apr 21

Covered everything I currently need.

George Winthorpe, GxP Quality Assurance Auditor, Animal and Plant Health Agency , Oct 20

Thoroughly enjoyed this 2-day interactive training course. Presentation content was very comprehensive and informative. Declan has a wealth of experience and shared practical knowledge/approach on how to handle common PV scenarios.

Oluwafemi Odugbesan, Boehringer Ingelheim Vetmedica GmbH, Oct 20

Good course.

Sean O'Sullivan, Bimeda Animal Health Ireland , Oct 20

Content: quite good. Too many abbreviations in the first two lectures, for newbies this is very frustrating. Presentation was way above expectations given the nature of it (webinar). Speaker also good, knew what he was talking about, mostly knew his audience and extreme level of intensity throughout the course.

Stian Mørch Aaen, Research Manager, Aqua Pharma Group, Oct 20

Very informative, interactive course with room for questions and discussion. I learned a lot of practical things and points to consider.

Marjolijn Verweij-Heemskerk, Junior Consultant Pharmacovigilance, DADA Consultancy BV, Nov 19

In general very interesting course.

Guy Werquin, Veterinary Doctor, Versele-Laga, May 19

Good general overview about pharmacovigilance. Talented and passionate speaker. Many practical examples.

Tom Decock, Regulatory Affairs, Versele-Laga, May 19

A good course to get a general introduction to Veterinary Pharmacovigilance, for those new to pharmacovigilance. The speaker, Declan O'Rourke, is very experienced and very enthusiastic in his presentation.

Anders Hessellund Bisgaard, QA & RA Assistant, Salfarm Danmark A/S, May 19

Very good course. Personally I would have needed more time on PSURs and signal detection and less on cases assessment. Very informative and enthusiastic.

Claire Biener-Milard , Pharmacovigilance Manager, Merial - Boehringer Ingelheim, May 19

[The speaker was] enthusiastic, clear and easy to understand. The material was relevant and well explained.

Donal Donnelly, Clinical Veterinary Surgeon and Deputy QPPV, DONAL DONNELLY, May 19

interesting, experienced speaker, great overview of pharmacovigilance.

Karen Roels, Clinical Trial Manager, Huvepharma NV, Nov 18

Enjoyed method of presenting.

Lisa Glen, Project Manager, Benchmark Animal Health, Nov 18