Veterinary medicines follow a strict regulatory framework to ensure the wellbeing of animals and to keep animals healthy in the food chain for human consumption.
This 2-day practical course is designed for the regulatory professional to give a complete guide to the regulatory guidelines surrounding the authorisation of veterinary medicinal products in the EU. The course will provide you with fundamental regulatory knowledge to help you unpick the complexity of the system and apply your knowledge to achieve fast product approval and effective product maintenance.
Over 2-days you will explore the regulatory landscape for veterinary medicines and examine the European licensing procedure for product approval. You will discuss in detail the submission process, analysing areas such as quality and efficacy.
Optional day 3 (standalone course)
This optional 1-day course is aimed at professionals working in pharmacovigilance (PV) or those wanting to discover more about post-market safety activities for veterinary medicines. On this 1-day course you will examine in greater detail the PV requirements for veterinary medicines, discover how to manage adverse events and learn how to prepare and submit Periodic Safety Update Reports (PSUR).
Dr Mel Munro has worked in the regulation of animal health medicinal products since 2002. In her currently role at the veterinary product development consultancy group, Triveritas, she is responsible for all aspects of veterinary vaccine development. Mel spends most of her time providing strategic and expert regulatory advice on new product developments including assisting clients with Start-to-Finish projects - taking ideas from proof of concept all the way through to Marketing Authorisation. In addition to providing regulatory strategy she also has extensive experience in the preparation of documents and dossiers for regulatory submissions and runs regulatory procedures on behalf of clients. Over her career she has been involved in the development of conventional veterinary medicinal products but more recently has worked on several high-tech products containing novel recombinant antigens and various novel veterinary biotherapeutics.
Dr Andrew Hewitt is a veterinarian who has been working in Veterinary Medicine Product Development in a clinical and regulatory capacity since 2007. In his current role with global animal health product development CRO Triveritas, Andrew manages regulatory affairs projects covering all aspects of product development and maintenance from early proof of concept right through to post authorisation work. Andrew also acts a back up Qualified Person for Pharmacovigilance (QPPV), delivering pharmacovigilance services for Triveritas and its clients. Taking advantage of previous experience as a clinical practitioner in the UK and investigator and monitor on clinical trials, Andrew brings a broad range of knowledge to regulatory projects and has a particular interest in strategic regulatory planning.
This course has been specifically designed for those working in the development of new veterinary medicinal products
"The course gave a clear overview of the different submission procedures and the requirements to be followed in the content of the dossier. The availability of the trainers for questions was great."
~ Regulatory Affairs Manager, Merial
Very enjoyable course with trainers that clearly know their stuff. Time given to ask questions was great.
The course definitely covered my needs. It was interactive and provided additional information.