Registration of Animal Feed Additives in the EU

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

5-6 Jun 2019

GBP 1,399
EUR 1,959
USD 2,182

Book now

Course overview

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

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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

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

Presenters

Elinor McCartney

Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and 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.

Laura Payo Lewis

Laura Payo Lewis is a regulatory consultant for the food and animal health industry. She has a masters in biotechnology from the University of Salamanca, and interned in the cell culture quality control department of Intervet/Schering-Plough Animal Health in 2010. She specialises in EU food and feed enzyme and probiotic registrations, and has developed expertise in US FDA regulatory requirements. Since 2011, she has been working at Pen & Tec Consulting, a regulatory affairs consultancy focused on helping companies to understand and comply with European food and feed laws in order to successfully sell their products and minimize their time to market. She currently runs the regulatory affairs department at Pen & Tec’s head office in Spain where she has managed multiple registration processes, gaining approval of food and feed products.

Book now

5-6 Jun 2019
5-6 Jun 2019 Holiday Inn London - Kensington Forum, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Alltech
  • Aveve Biochem
  • Bayer Animal Health GmbH
  • Chr. Hansen A/S
  • Clariant Produkte (Deutschland) GmbH
  • Devenish Nutrition Limited
  • DuPont Industrial Biosciences
  • Elanco Animal Health
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Herbonis Animal Health GmbH
  • Huvepharma
  • In Vivo NSA
  • Kemin
  • Kemin Europa SA/NV
  • LUCTA, S.A.
  • METABOLIC EXPLORER
  • Ministry of Agrarian Policy and Food of Ukraine
  • Novus Spain SA
  • Nutreco Nederland BV
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Nutrition Sciences NV
  • Orion Pharma
  • OXEA GmbH
  • Phibro Animal Health Corporation
  • Probiotics International Ltd
  • University College Cork
  • Vetagro S.p.A.
  • Zinpro
  • Zoetis Belgium S.A.

The speakers were very knowledgeable and well prepared and equipped to answer questions. The exercises were very helpful. The course was well researched, up to date and very useful.

Jason Keegan, Regulatory Research Specialist, Alltech

[The speakers] were both very good and engaging. A very good, informative course that was well delivered.

Harry Ancill, Regulatory Affairs Assistant, Probiotics International Ltd

Excellent presentation. Good interaction, very clear explanation.

Kalinka Grozeva, Quality Control Director, Vetagro S.p.A.

[The course had] clear structure, very lively presentation. Definitely worthwhile coming.

Günther Becker, Director, OXEA GmbH

Nice package, but I think there were a bit too much information in two days.

Jouni Heikkinen, Laboratory Director, Biosafe - Biological Safety Solutions Ltd/Oy

Very dense in information, as expected. The experience of the speakers makes a lot of different because many different examples were presented.

Simone Midori Costa, Registration Specialist, Trouw Nutrition

Excellent content, excellent speakers.

Pauliina Halimaa, Product Manager, Bioinformatics, Biosafe - Biological Safety Solutions Ltd/Oy

Extremely satisfied. I have learnt a lot about the feed additives and the regulatory frame work. Truly appreciated the speakers and their clear presentations.

Mohammed Boularas, Senior Associate Regulatory Affairs, Zoetis Belgium S.A.

Interesting and relevant course.

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd

My expectations were met and course was very well organised

Elisa Salvetti, Marie S. Curie Research Fellow, University College Cork

Excellent content, some information on the slides was a bit small to read, but overall excellent content

Stephanie Allen, Regulatory Affairs Associate, Danisco UK Ltd