This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
This course will provide a comprehensive introduction to the entire regulatory dossier submission for approval of a feed additive in the EU, taking participants through all the necessary steps to obtain marketing authorisation. Presentations will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different types of feed additives. An important part of the programme will be devoted to working on case studies in the workshop sessions.
Key areas covered and course objectives:
- Regulatory affairs
- Product development
Introduction and objectives of the course
EU regulatory framework – the basic legislation and procedures
EURL and EFSA guidance documents
Workshop: Strategic planning – matching commercial and regulatory objectives
Section II – Identity
Section II – Requirements for microorganisms intended for use as additives or production strains
*Workshop: Building Section I*I
Section III – Safety for target animals, consumers, users and the environment
Review of day one -– discussion, questions and answers
Workshop: Building Section III
Section IV – Efficacy
Good study design – ticking EFSA boxes
Workshop: Building Section IV
Writing and managing the dossier
Final discussion, questions and answers
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.