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Registration of Animal Feed Additives in the EU (European Union) 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.
20-21 Jun 2022
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. Since the 27th of March this year, the new EU Transparency Regulation (EU) 2019/1381 has applied to all regulated products in the food chain, including feed additives. This means big changes to the way that food business operators/applicants write & submit their feed additive dossiers.
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 in line with the new EU regulation on transparency.
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. We will also focus on the Transparency Regulation and explain the new procedure for feed additive approvals.
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, and learn about how the new EU Regulation on Transparency will affect the feed additive approval process
- 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
This online seminar is brought to you by Pen & Tec´s regulatory experts. The format will be as interactive as possible and will be composed of a series of lectures, workshops, questionnaires, and online polls.
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
Presenter
Elinor McCartney (More...)
Dr Elinor McCartney 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.
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20-21 Jun 2022 Live webinar |
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20-21 Jun 2022 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 16 May 22* |
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* Note the early booking discount cannot be combined with any other offers or promotional code