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 take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union. 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 course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire regulatory dossier submission for approval of a feed additive in the EU.

Who should attend?

Managers in the following areas:

  • Regulatory Affairs
  • Research and Development
  • Product Development and Marketing
  • Scientists in contract research organisations where clients demand EFSA-compliant studies
    The course will also be valuable to those seeking to review special problems encountered in the registrations of feed additives in the EU. There will be ample opportunity for discussion during the proceedings.

Key areas covered and Benefits

  • Understand the EU Regulatory Framework – 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 & 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

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...

  • Alzchem AG
  • Bayer Animal Health GmbH
  • Biosafe - Biological Safety Solutions Ltd/Oy
  • Clariant Produkte (Deutschland) GmbH
  • Danisco UK Ltd
  • 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
  • Lohmann Animal Health GmbH
  • LUCTA, S.A.
  • 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
  • Phibro Animal Health Corporation
  • Probiotics International Ltd
  • Trouw Nutrition
  • University College Cork
  • Vetagro S.p.A.
  • Zinpro
  • Zoetis Belgium S.A.

[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

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

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

Günther Becker, Director, OXEA GmbH

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

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

Excellent presentation. Good interaction, very clear explanation.

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

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, excellent speakers.

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

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