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 Europe. As the market for veterinary products grow, so too do the requirements for regulatory compliance on a global scale. The course will focus on the latest Directive and its impact on your marketing applications in an enlarged Europe.
Dr Mel Munro
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 MRCVS
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 to address the needs of those working in the following areas:
Experienced Trainers and Discussions