Veterinary Pharmacovigilance in the EU Course: Implications of the Proposed EU Pharmacovigilance Legislation and Brexit (London, United Kingdom - November 6, 2019)

DUBLIN, Oct. 15, 2019 /PRNewswire/ -- The "Introduction to Veterinary Pharmacovigilance" conference has been added to ResearchAndMarkets.com's offering.

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
• Strategies for follow-up

Pharmacovigilance case studies

Programme Day 2

Electronic communication in pharmacovigilance

• Reporting in EV Vet
• VEDDRA

Minimising the impact of data with errors

• Consistent assessment and coding

Clinical trial AE reporting requirements

• Post-authorisation safety studies
• Phase IV studies

Literature searches

• Peer-reviewed worldwide literature
• Local journals and magazines

Periodic safety update reports (PSURs)

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

Practical workshop on PSURs

For more information about this conference visit https://www.researchandmarkets.com/r/pkienk

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SOURCE Research and Markets