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.
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.
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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 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).