26 - 27 April 2017, Rembrandt Hotel, London
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 in Attending:
Understand the phased-submission process for vaccine licensing
Learn the format and content specifications for the required dossier components
Review the USDA regulations (9 CFR) and guidance (memoranda, notices, supplemental information formats (SIF), supplemental assay methods (SAM)
Compare the regulatory fee structures (no fees for USDA-licensing, minimal fees for Canadian licensing of biologics)
Programme Day One
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 Two
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
Standard enrolment £1349