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.
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
Get to grips with literature searches
Understand the implications of the proposed EU pharmacovigilance legislation and Brexit
Who Should Attend:
This 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.
Agenda:
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
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