This course will provide a comprehensive introduction to the entire regulatory dossier submission for the approval of a feed additive in the EU, taking participants through all the necessary steps to obtain marketing authorisation.

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

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

Elinor McCartney

Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and is dedicated to providing specialist services in new product development and registration of feed additives in Europe. She has managed the growth of services to include all categories of feed additives. Elinor is a graduate of the Royal Veterinary College, where she obtained her PhD in enteric diseases of piglets. She also holds an MBA (with distinction) from the Open University and has tutored in Finance and Marketing for the Open University Business School in several European countries.
Elinor has worked in general veterinary practice, in the veterinary pharmaceutical industry and in various technical and commercial roles concerning the supply of additives and speciality ingredients to the feed industry. Elinor helps clients understand EU/EFSA legislation, guidelines and guidance and has assisted many applicants to achieve or maintain EU approval of a wide range of products, including, technological, sensory, nutritional, zootechnical and coccidiostat feed additives.

Day 1:

• 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 II
• Section III – Safety for target animals, consumers, users and the environment

Day 2:

• 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
  • Post-marketing monitoring plan
  • EFSA completeness check
  • Quality control, submission and follow-up
  • Handling EFSA clock-stops
• Final discussion, questions and answers

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