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. As the market for veterinary medicinal products grows, so too do the requirements for regulatory compliance. The course will provide you with the fundamental regulatory knowledge to unpick the complexity of the system and apply your knowledge to achieve fast product approval and effective product maintenance.
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 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 and biopharmaceutical product development. Mel spends most of her time providing strategic and expert regulatory advice on all aspects of new product developments - 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 successful development of broad range of veterinary medicinal products ranging from conventional to high-tech.
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.