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
This 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.
Benefits of attending:
Gain an overview of the European regulatory framework
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
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.
Welcome and Introduction
What is Pharmacovigilance?
The Current Regulatory Framework and its Global Impact
Adverse Event Reporting
Pharmacovigilance Case Studies
Electronic Communication in Pharmacovigilance (including VEDDRA)
Minimising the Impact of Data with Errors
Clincal Trial ADR Reporting Requirements
Periodic Safety Update Reports
Practical Workshops on PSURs
Discussion will take place throughout the two days
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).