This In-house course 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.
The purpose of this In-house course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.
This In-house course will provide a comprehensive introduction to the entire development programme for companion animal medicines.
In this In-house course, discover how to develop veterinary pharmaceuticals and vaccines, its regulatory landscape and how you might apply these principles to novel biotherapeutics.
A basic In-house 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.
This In-house course will take many aspects of animal health and veterinary research and development through a typical clinical trial and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and CVMP.
This In-house course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
This In-house course provides an insight into the licensing of veterinary vaccines by USDA and CFIA, the phased submission process for vaccine licensing, and both format and content specifications for the required dossier components.
This In-house coursewill cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions