This meeting 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.
10-11 Mar 2020
This seminar has been designed to give practical advice and guidance on how to successfully develop a veterinary vaccine and achieve market approval in the EU. The programme will take a step-by-step approach to the process with a workshop to help delegates gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.
Benefits of attending:
This meeting runs back-to-back with Registration of Veterinary Vaccines in the USA and Canada on 12 March 2020 and there is a £200/€280 discount off when booked together with this programme.
To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail email@example.com
This seminar will be beneficial to all those working with veterinary vaccines from development to market approval and will provide a comprehensive insight into the requirements to achieve a successful application.
The programme will be of particular interest to:
A practical guide to the EU regulatory framework for veterinary vaccines
Meeting the requirements of the marketing authorisation dossier – Part 2: Quality
Meeting the requirements of the marketing authorisation dossier – Part 3: Safety
Meeting the requirements of the marketing authorisation dossier – Part 4: Efficacy
Using the summary of product characteristics (SmPC) as a tool for development
Planning a vaccine development – introduction and workshop
Workshop – groups report back and Q&A
Seeking regulatory advice and development of novel vaccines
Procedures aimed at promoting innovation and vaccine availability
Preparing the dossier submission
European licensing procedures and regulatory strategy
Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration since 2002. She provides regulatory advice on all areas of VMP development taking ideas for veterinary medicines from proof of concept right through to Marketing Authorisations (MA). On a day-to-day basis, she advises on regulatory strategy, performs technical due diligence and gap analyses and prepares strategic development plans and expert reports. She is also experienced in negotiation with the regulators, preparing reports, documents and dossiers to support MA submissions as well as managing regulatory procedures and assisting clients with regulatory referrals. Over her career she has been involved in various biologicals development projects ranging from more ‘conventional’ vaccines to novel biologicals containing products of rDNA technology and GMO’s.
Dr Tamsin Dawson has worked in the development and regulation of animal health products since 2005, having started her career in analytical method development. In her current role at the veterinary product development consultancy group, Triveritas, she supports clients on a range of veterinary vaccine, pharmaceutical, and feed additive product developments and registrations. This includes assessing the suitability of data for a European submission, as well as writing reports and dossiers for regulatory submissions, managing regulatory procedures, and responding to assessor’s questions on behalf of clients.