Courses

Regulatory

This meeting has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual conference now in its 6th successful year.

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.

Advanced Veterinary Pharmacovigilance

11-12 Dec 2019

Also on: 23 Jun 2020

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.

Introduction to Veterinary Pharmacovigilance

5-6 Nov 2019

Also on: 5 May 2020

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

We can customise this course to meet your requirements.

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

The programme will offer a comprehensive introduction to the new legislation Regulation (EU) 2019/6 and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers. NEW EVENT!

An updated brochure will be available shortly!

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions

Veterinary Pharmaceutical Submissions in the EU

26-27 Nov 2019

Also on: 24 Mar 2020

This practical four day course provides a comprehensive understanding of a veterinary medicine development in the EU and USA.