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.
30 Apr-1 May 2019
GBP 1,399 1,199 *
EUR 1,959 1,679 *
USD 2,182 1,870 *
* When you book before 26 Mar
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 2 May 2019 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
Mel Munro has worked in regulatory affairs in the Animal Health Industry since 2002. She has been involved in all aspects of veterinary 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). On a daily basis she is responsible for preparing reports, documents and Dossiers for MA submissions, and for running National, Decentralised and Centralised Procedures. She also provides gap analysis of existing products and strategic advice on new product developments. Over her career she has been involved in various vaccine development projects ranging from inactivated and live viral and bacterial vaccines, to novel vaccines that include 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.