2-Day Seminar: A Practical Approach to Veterinary Vaccine Development & Registration in the EU (London, United Kingdom - April 30, 2019 - May 1, 2019) - ResearchAndMarkets.com

The "A Practical Approach to Veterinary Vaccine Development and Registration in the EU" conference has been added to ResearchAndMarkets.com's offering.

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.

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.

Benefits of Attending

• Recognise the key legislation and guidance and how to use this to plan an effective veterinary vaccine development
• Understand what data you need to generate for your application and how to present this in your dossier
• Gain an insight into the different routes to market and how to submit your dossier for Market Approval (MA)
• Learn how and when to seek regulatory advice during development
• Consider the implications of the ongoing review of the Veterinary Medicines Regulation

Who Should Attend?

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:

• New entrants to Registration Departments
• Veterinary Medicinal Product Manufacturers
• Registration Managers
• Personnel within Research and Development Departments
• Academics with an interest in commercialising opportunities
• Personnel from Micro/Small Enterprises

Agenda

Programme - Day 1

A Practical Guide of EU Regulatory Framework for Veterinary Vaccines

• Regulatory bodies & key legislation and guidance
• Update on the legislation review

Marketing Authorisation

• Dossier - Part 2: Quality

Marketing Authorisation

• Dossier - Part 3: Safety

Marketing Authorisation

• Dossier - Part 4: Efficacy

• Using SPCs as a Tool for Development

Programme - Day 2

Planning a Vaccine Development - Workshop

Workshop - Groups Report Back and Q&A

Seeking Regulatory Advice During Planning and Development of Novel Vaccines

• Scientific Advice, Innovation Task Force (ITF)

Procedures Aimed at Promoting Innovation

*Minor use / Minor species (MUMS) classification, Small/medium enterprise (SME) designation

Preparing the Dossier Submission

• Marketing Authorisation Dossier - Part 1: Administrative documentation, DACS and Benefit Risk Assessments, Product Information and Labelling
• Tips on e-Submissions

European Licensing Procedures and Regulatory Strategy

For more information about this conference visit https://www.researchandmarkets.com/research/2mhltw/2day_seminar_a?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005301/en/