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 is a Regulatory Project Manager at Triveritas. Mel has worked in regulatory affairs in the Animal Health Industry since 2002. She has been involved in all aspects of veterinary pharmaceutical and vaccine development and spends most of her time assisting clients with Start-to-Finish projects, taking ideas for veterinary medicines from proof of concept right through to Marketing Authorisations (MA). In addition to providing strategic advice on new product developments she also prepares gap analyses of existing data packages. On a daily basis, Mel is responsible for advising on regulatory strategy and product development, preparing documents and dossiers for regulatory submissions, and for running regulatory procedures on behalf of clients.
Mr Andrew Hewitt is a veterinarian with over 7 years in Veterinary Medicine Product Development in a clinical and regulatory capacity. In his current role with Triveritas, Andrew manages regulatory affairs projects. 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. Andrew frequently engages with the regulatory authorities, with particular experience in areas such as Minor Use Minor species and Parallel Scientific Advice between EU and US authorities. Andrew is also involved in delivery of pharmacovigilance services for Triveritas.
This course has been specifically designed to address the needs of those working in the following areas:
Experienced Trainers and Discussions