DUBLIN--(BUSINESS WIRE)--The "Registration of Animal Feed Additives in the EU" conference has been added to ResearchAndMarkets.com's offering.
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:
- Understand the EU regulatory framework and relevant legislation
- Roles of the EU Commission, the EURL, EFSA and Member States
- Types of feed additives and acceptable claims
- Data required - product characterisation safety, quality and efficacy
- EC, EURL and EFSA guidelines and guidance documents
- How to conduct a strategic data audit and gap analysis
- Managing EU registration projects
- Writing successful feed additive dossiers
- Post-submission hurdles - dossier validation and EFSA clock-stops
- Interacting with the EU Commission, Member States and EFSA
Agenda
Programme Day One
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
Programme Day Two
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
Workshop presentations
- Presentation by each team
- Review and discussion
Writing and managing the dossier
- Writing the dossier
- Post-marketing monitoring plan
- EFSA completeness check
- Quality control, submission and follow-up
- Handling EFSA clock-stops
Final discussion, questions and answers
For more information about this conference visit https://www.researchandmarkets.com/r/de84zc