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Basics of Veterinary Regulatory Affairs

Level:
Foundation
Area:
Drug Development
Code:
DDF51
Duration:
03:30:00
Workshop profile:
This workshop is aimed at medical writers, both new and experienced, who would like to improve their understanding of veterinary regulatory affairs. This is a foundation level workshop. No previous knowledge of veterinary regulatory affairs is assumed, but experience in the Market Authorisation of pharmaceuticals would be helpful. This workshop is expected to be of benefit for personnel working in Regulatory Affairs, Research and Development, Clinical Trials and Marketing.
Objective:
Workshop participants will be introduced to the field of veterinary regulatory affairs. A short introduction to the EU Regulatory Framework and different legal routes (procedures) and legal bases to authorisation will be followed by an overview of the basic content and structure of a typical dossier for Veterinary Medicinal Products (VMPs). Veterinary regulatory documents to be written by medical writers will be discussed. Participants will gain a good broad understanding of this area of regulatory affairs, which they can use to their benefit when working in this area.
Content:
· Overview of current and future EU VMP regulatory framework · EU Marketing Authorisation procedures · Structure and content of a VMP dossier · Other veterinary regulatory documents The topics above will be covered by initially presenting the information, followed by interactive question and answer sessions which will allow everyone to participate.