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Registration of Animal Feed Additives in the EU Seminar: Roles of the EU Commission, the EURL, EFSA and Member States - London, United Kingdom - June 5-6, 2019

DRUCKEN

DUBLIN, May 21, 2019 /PRNewswire/ -- The "Registration of Animal Feed Additives in the EU" conference has been added to ResearchAndMarkets.com's offering.

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:

  • 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

Who Should Attend:

  • Managers working in:

- Regulatory affairs
- Marketing
- R&D
- Product development

  • Scientists in CROs where clients demand EFSA-compliant studies
  • Those seeking to review special problems in the registration of feed additives in the EU

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/qwvbyd

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Cision View original content:http://www.prnewswire.com/news-releases/registration-of-animal-feed-additives-in-the-eu-seminar-roles-of-the-eu-commission-the-eurl-efsa-and-member-states---london-united-kingdom---june-5-6-2019-300854156.html

SOURCE Research and Markets

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