Introduction to Veterinary Pharmacovigilance

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.

15-16 May 2019

& 5-6 Nov 2019

GBP 1,399
EUR 1,959
USD 2,182

Book now

Course Overview

This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacogivilance. New entrants and support staff as well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will be plenty of time for interaction and questions and answers to enable participants to get a good understanding of this complex subject.

Benefits of attending:

  • Gain an overview of the European regulatory framework n Be aware of Volume IXb
  • Learn about VICH
  • Understand adverse event reporting
  • Hear about causality assessment
  • Minimise the impact of data with errors
  • Know the requirements for periodic safety update reports
  • Literature searches explained
  • Understand the implications of the proposed EU pharmacovigilance legislation and Brexit

Who should attend?

This course will be beneficial for 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 find this seminar useful.

Sample Programme Day 1

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, including Volume IXb and implications of the proposed EU pharmacovigilance legislation
  • Implications for global environment – link to VICH
  • Practical applications of definitions

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

Pharmacovigilance case studies

Sample Programme Day 2

Electronic communication in pharmacovigilance

  • Reporting in EV Vet

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

Periodic safety update reports (PSURs)

  • Format and content of the PSUR
  • Analysis of data
  • Incidence calculation
  • Compliance and the PSUR
  • Addendum reports
  • Bridging reports

Practical workshop on PSURs


Declan O'Rourke (15-16 May 2019)

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

Declan 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 Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

Declan is also an Honarary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Past President of British Cattle Veterinary Association and a member of the Veterinary Products Committee (VPC).

Book now

15-16 May 2019
15-16 May 2019 DoubleTree by Hilton London-West End, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
5-6 Nov 2019
5-6 Nov 2019 DoubleTree by Hilton London-West End, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • ACD Pharmaceuticals
  • Animlacare
  • Bayer
  • Beaphar BV
  • Benchmark Animal Health
  • Boehringer Ingelheim Denmark A/S
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Cyton Biosciences Ltd
  • DADA Consultancy
  • Eco Animal Health Group plc
  • Huvepharma
  • Huvepharma NV
  • Jurox Pty Limited (Australia)
  • Knowledgepool Group Limited
  • MSD Animal Health SRL
  • Norbrook Laboratories Ltd
  • Pharmacosmos
  • Pharmacovigilance Matters Limited
  • Pharmaq
  • Pharmaxim AB
  • Salfarm Danmark A/S
  • Seacalx AS
  • SSCL Animal and Plant Health Agency
  • Swedish Medical Products Agency
  • TBC
  • Triveritas Limited
  • Vetcare Oy
  • Veterinary Medicines Directorate

Structured, logical and critical approach to a complex case handling.

Maud Christelle Ricatti, DVM, ACD Pharmaceuticals

Very good

Luciano Gobbi, Associate Director Regulatory Affairs, MSD Animal Health SRL

Overall I was very impressed with the course

Lee Smith, Pharmacovigilance E9O, Veterinary Medicines Directorate

Very good

Felicity Caddick, veterinary technical advisor, Animlacare

Interesting and informative course. Enthusiastic and informative speaker.

Hannah Robbins, Pharmacovigilance VRO, Veterinary Medicines Directorate

Good knowledge sharing, open dialogue, not all slides in the binder up to date, overall very positive

Angela van der Salm, Director Pharmacovigilance, DADA Consultancy

Relevant, good course

Katrine Underlien, Drug Safety Coordinator, Pharmacosmos

I think that this course is great for people looking for more insight into pharmacovigilance and would recommend it

Jamie Jardine, Administrative Officer, Veterinary Medicines Directorate

Very interesting program, well organized, with a very experienced speaker, with good presentation technique and with a good ability to capture the interest of the participants. the presentations were clear and interesting.

Marlene Delgado, QPPV, ZOOPAN S.A.