Animal Health - Session 4: Pharmacovigilance – Moving to the new signal management system (EU and UK)

Are you ready for the new veterinary Regulation?

Implementation of the new veterinary medicines regulation in the EU (Regulation 2019/6, or the new VMP-Reg) took place on January 28th, 2022.

For two decades, the EU legislation around veterinary medicines has remained largely the same; clarifications have been made of certain scientific and legal aspects of Directive 2001/82 EC as amended, and the associated legislation and guidelines – but essential principles have not changed during this time. The new VMP-Reg represents a significant departure from the ‘old’ legislation for all of us - from Marketing Authorisation Holders to manufacturers, from regulatory affairs strategists to clinical study monitors.

The Animal Health Team at knoell have prepared this series of e-learnings, providing expert insights into the content of the new VMP-Reg from different perspectives and within different contexts.

This fourth presentation explores the significant changes to veterinary pharmacovigilance requirements and processes that have come about since the new VMP-Reg came into force, as well as ‘air-gap’ mitigations currently used in the UK, and looking ahead to the expected changes to UK pharmacovigilance when the Veterinary Medicines Regulations (VMRs) are revised (the VMD consultation is expected to begin in Autumn 2022). Content of the presentation includes:

  • Requirements for Signal Management
  • Frequency
  • Process
  • Reporting
  • The Annual statement
  • Practical approaches to managing the two systems in parallel (EU and UK)

 

Interested in latest news on Animal Health Regulations? Click here!

Informationen
Zielgruppe: 
Marketing Authorisation Holders, Manufacturers, Importers, Distributors and Regulatory Affairs professionals all in the field of veterinary medicines, specifically vet pharmaceuticals.
Sprache: 
Englisch
Sprache der Schulungsunterlagen: 
Englisch