Introduction to Veterinary Pharmacovigilance

A basic In-house 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.

In-house Training and Consultancy Services

This In-house course has been designed to provide basis training and a good introduction to those concerned with Veterinary Pharmacovigilance. New entrants, support staff we 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, questions and answers to enable participants to get a good understanding of this complex subject.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

Welcome and Introduction*

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
  • 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 two

Electronic Communication in Pharmacovigilance (including VEDDRA)

Minimising the Impact of Data with Errors

Clincal Trial ADR Reporting Requirements

Literature Searches

Periodic Safety Update Reports

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

Practical Workshops on PSURs

Discussion will take place throughout the two days

Recommended trainer

Declan O’Rourke

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 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).