VETERINARY
PHARMACEUTICAL
SUBMISSIONS IN THE EU

Conference Date: 23-24 Mar 2009
Conference Ref: V3-8309
Fee: £1100 + VAT
Venue: The Rembrandt Hotel, London

INTRODUCTION

This seminar will take the participants through all the constituent parts of the application for marketing authorisation for a veterinary medicinal product for which a marketing authorisation is sought in the European Union.  Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Expert Reports and regulatory submissions.  An important part of the course will be devoted to working on case studies in the workshop sessions.

The course will provide a comprehensive introduction to the entire regulatory dossier for a veterinary medicinal product in the European Union.