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.
16-17 Oct 2018
& 30 Apr-1 May 2019
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 participants through a step-by-step approach to the process. The workshop will assist delegates to gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.
This meeting runs back-to-back with Registration of Veterinary Vaccines in the USA and Canada on 20 October 2017 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 firstname.lastname@example.org
Recognise the key legislation and guidance and how to use this to plan an effective veterinary vaccine development
This seminar will be beneficial to all those working with Veterinary Vaccines from development to market approval and will provide a comprehensive insight to the requirements to achieve a successful application.
Personnel in the following areas will find this course useful:
A Practical Guide of EU Regulatory Framework for Veterinary Vaccines
Using SPCs as a Tool for Development
Planning a Vaccine Development – Workshop
Workshop – Groups Report Back and Q&A
Seeking Regulatory Advice During Planning and Development of Novel Vaccines
Procedures Aimed at Promoting Innovation
*Minor use / Minor species (MUMS) classification, Small/medium enterprise (SME) designation
Preparing the Dossier Submission
European Licensing Procedures and Regulatory Strategy
Juliet Greenslade has over 19 years experience working in the Animal Health Industry. Her degrees are in Immunology and Medical Microbiology. She started her career as a Medical Microbiologist in a large teaching hospital (5 years) before moving into the Animal Health arena. Initially she worked as a Scientist and GLP study Director in Biologicals R&D at Intervet. After some 6.5 years doing this she moved into Regulatory Affairs, first with Schering-Plough as a Senior Regulatory Manager and then with Pfizer (now Zoetis) as an Associate Director before joining Triveritas in 2010. During her time working in “big pharma”, she took responsibility for developing and registering new products, life-cycle maintenance of existing products and advising on regulatory strategy. In her current role as Project Manager, Biologicals Regulatory Affairs, at Triveritas, she assists clients (large and small) in a variety of areas, from advising on regulatory strategy and product development, through to preparing Expert Reports, writing Dossiers and running regulatory procedures on behalf of clients.
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.