Introduction to Veterinary Pharmacovigilance Training Course (ONLINE EVENT: June 26-27, 2024)

This two-day event has been designed to provide an essential overview of veterinary pharmacovigilance and will offer practical guidance and basic training for all those working in drug safety in the EU.

Our experienced trainer will clarify roles and responsibilities, explain commonly used terminology and take participants through all the key aspects of this complex subject. There will be plenty of time for interaction and questions and answers to enable participants to get a good understanding of the issues involved. The use of industry case studies will demonstrate real-life scenarios to help embed learning.

Benefits of attending:

• Gain an overview of the European regulatory framework
• Understand the requirements of the new EU pharmacovigilance legislation
• Learn about VICH
• Understand adverse event reporting
• Hear about causality assessment
• Minimize the impact of data with errors
• Get to grips with literature searches
• Understand UK PV requirements post-Brexit

Certifications

• CPD: 12 hours for your records
• Certificate of completion

Agenda

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, the EU pharmacovigilance legislation
• Implications for global environment - link to VICH
• Practical applications of definitions
• Role of the MAH
• Role of the NCA/EMA
• Role of the QPPV

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

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

PSURs

• VMD (UK), VDD (Canada) and APVMA (Australia) requirements
• Format and content of the PSUR
• Analysis of data
• Incidence calculation
• Compliance and the PSUR

Practical workshop on PSURs

For more information, please visit: "Introduction to Veterinary Pharmacovigilance Training Course"