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Regulatory

This event 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.

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Advanced Veterinary Pharmacovigilance

25-26 Nov 2020

Also on: 23 Jun 2021

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.

INCLUDES: Interactive workshop and discussion sessions

Introduction to Veterinary Pharmacovigilance

14-15 Oct 2020

Also on: 20 Apr 2021

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

NEW EVENT!

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.

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 EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

INCLUDES: Interactive discussion sessions

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

18-19 Nov 2020

Also on: 16 Mar 2021

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