DUBLIN--(BUSINESS WIRE)--The "Introduction to Veterinary Pharmacovigilance" conference has been added to Research and Markets' offering.
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 in 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
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 useful. seminar
Agenda:
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
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
For more information about this conference visit https://www.researchandmarkets.com/research/7458cn/introduction_to
