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Registration of Animal Feed Additives in the EU Training Course

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

14-15 Jun 2021

& 16-17 Jun 2021

Book now

Details

Course overview

The EU has transformed its food legislation in the last two decades, creating the European Food Safety Authority (EFSA) and adopting a harmonised approach to food safety ‘from farm to fork’. The Feed Additives Regulation (Regulation (EC) No 1831/2003), which applies to all feed additives and pre-mixtures, establishes a common procedure across the EU for authorising animal feed additives and lays down rules for their placing on the market, labelling and use.

Obtaining marketing approval for a feed additive in the EU is complex and this practical and interactive two-day course will provide a comprehensive introduction to the entire regulatory dossier submission, 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, which have been designed to help consolidate learning, and there will be ample time for discussion with our expert faculty.

Benefits of attending:

  • Gain a comprehensive overview of the EU regulatory framework and relevant legislation
  • Understand the roles of the EU Commission, the EURL, EFSA and Member States
  • Discuss types of feed additives and acceptable claims
  • Clarify the data required – product characterisation safety, quality and efficacy
  • Get to grips with EC, EURL and EFSA guidelines and guidance documents
  • Learn how to conduct a strategic data audit and gap analysis
  • Better manage EU registration projects
  • Master the art of writing successful feed additive dossiers
  • Discuss post-submission hurdles – dossier validation and EFSA clock-stops
  • Know how to interact 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

Course 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 II

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

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

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 (More...)

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.

Joan Castelló (More...)

Joan Castelló is as a regulatory consultant for the food and animal health industry since 2018. He holds a bachelor’s degree in chemistry (Lindenwood University, USA), specialising in biochemistry. Joan gained experience in food chain safety while working as an analyst at a food microbiology testing laboratory in London, UK. Since joining Pen & Tec in 2018, Joan has been involved on the registration of feed additives in the EU as well as on the design of EFSA-compliant registration studies, and has also developed expertise in US FDA regulatory requirements.

Book now

Book now

14-15 Jun 2021
Face-to-face, (venue not yet confirmed)
14-15 Jun 2021
Face-to-face
(venue not yet confirmed)
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 3 May 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
16-17 Jun 2021
Live webinar
16-17 Jun 2021
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 5 May 21*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Alltech
  • Aveve Biochem
  • Biosafe - Biological Safety Solutions Ltd/Oy
  • Clariant Produkte (Deutschland) GmbH
  • DuPont Nutrition&Biosciences
  • Elanco Animal Health
  • Elanco Tiergesundheit AG Zweigniederlassung Österreich
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Herbonis Animal Health GmbH
  • Kaesler Nutrition
  • Kemin
  • Kemin Europa SA/NV
  • Lohmann Animal Health GmbH
  • LUCTA, S.A.
  • METABOLIC EXPLORER
  • MicroSynergies
  • Novus Spain SA
  • Nutreco Nederland BV
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Nutrition Sciences NV
  • Orion Corporation Orion Pharma
  • Orion Pharma
  • Phibro Animal Health Corporation
  • Probiotics International Ltd
  • Trouw Nutrition
  • University College Cork
  • Vetagro S.p.A.
  • Zinpro
  • Zoetis Belgium S.A.

It was a friendly atmosphere and the content , pace and the subjects were expertly chosen. I would gladly attend another course from Elinor and Ana. Both of them had a lovely attitude and clearly experts in their areas.

Cana Eisenhauer, Regulatory Manager, Kaesler Nutrition, Jun 19

Very knowledgeable. Excellent.

Kehinde Aigberua, Consultant, Quality Auditor, Elanco Animal Health, Jun 19

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

Günther Becker, Director, OXEA GmbH, May 18

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, May 18

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, May 18

Excellent presentation. Good interaction, very clear explanation.

Kalinka Grozeva, Quality Control Director, Vetagro S.p.A., May 18

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, May 18

[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, May 18

Interesting and relevant course.

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd, May 17

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., May 17

Excellent content, excellent speakers.

Pauliina Halimaa, Product Manager, Bioinformatics, Biosafe - Biological Safety Solutions Ltd/Oy, May 17

My expectations were met and course was very well organised

Elisa Salvetti, Marie S. Curie Research Fellow, University College Cork, May 17

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, May 16