Practical Course: A Regulatory Update on Animal Feed and Feed Additives in the EU (European Union) and USA – online seminar brought to you by Pen & Tec´s regulatory experts jointly with Management Forum
Pen & Tec Consulting, together with Management Forum, will deliver this practical and interactive two-day course that will review EU legislation, examine procedures and data requirements, and discuss to what extent EFSA-compliant data can be used to achieve approvals in the USA (or vice versa).
The registration is open.
Meeting regulatory requirements for feed and feed additives key markets in Europe and the USA are major challenges for businesses in the field of animal health and nutrition.
This seminar will review current EU legislation and EFSA guidance, examine procedures and data requirements, and discuss to what extent EFSA-compliant data can be used to achieve approvals in the EU, including UK/GB and the USA.
- Update on feed/feed additive legislation in the EU (and UK/GB post-BREXIT)
- The changing face of EFSA – effects of the Transparency Regulation
- EU 10-year renewals – a smaller hurdle for approved feed additives?
- EU/EFSA procedures and timelines in relation to feed additive applications
- Permitted claims onfeeds, veterinary medicines and feed additives – Europe vs. USA
- US FDA approaches to the regulation of nutritional products for animals
Managers working in:
- Business development
- Feed business operators
- Strategic marketing managers
- Registration managers
- Product managers
- R&D scientists
- Project managers
- Senior managers seeking a ‘snapshot’ of current regulatory trends and challenges in feeds and feed additives in Europe and the USA.
Dr Eliana Henriquez Rodriguez is an Agricultural Engineer with applied experience in animal production and research. Eliana holds a MSc in Animal Breeding and Reproduction Biotechnology (Autonomous University of Barcelona and Polytechnic University of Valencia, Spain) as well as a PhD in Agricultural and Food Science and Technology (University of Lleida, Spain). Eliana’s thesis focused on the validation of genetic markers to improve pork quality and generated results published in different peer-reviewed journals. In addition to working as a supervisor on pig farms in Venezuela, Eliana’s experience in industry and academia also includes an internship with Pig Improvement Company (USA) and a laboratory research project at TEAGASC Food Research Centre (Ireland), as part of her PhD training.
Throughout her professional and academic life, Eliana has developed skills in animal production management, molecular genetic techniques, experimental design, statistical analysis and scientific writing. In her role at Pen & Tec Consulting, Eliana is responsible for providing internal & external regulatory & scientific training for EFSA- compliant studies, and manages feed additive registration projects.
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.
Laura Payo Lewis
Laura Payo Lewis specialises in both EU food and feed product registrations. She is an experienced regulatory manager, helping numerous clients take their products to market, such as enzymes used as animal digestibility enhancers or as food processing aids. She holds a Master in Biotechnology from the University of Salamanca, and interned in the cell culture quality control department of Intervet/Schering-Plough Animal Health in 2010.
Laura has delivered seminars on regulations and procedures for registering feed and feed additives in the EU. She also provides training sessions for client regulatory teams on all aspects of the EU registration process, on topics such as understanding data requirements for the risk assessment of food and feed products derived from genetically modified microorganisms. Since joining Pen & Tec in 2011, Laura has acquired a deeper knowledge of the regulatory requirements in other jurisdictions, working on Food Additive Petitions or GRAS determinations (US FDA) or feed additive registrations in Brazil.
The role of the EU and Comitology
- Scope of EU feed additive legislation – in or out of scope?
- Differences between feeds, feed additives and veterinary products
- Feed and feed additive claims – best practices
- Post-EFSA opinion – comitology
- Special case of supplementary dossiers
EFSA’s risk assessment of feed additives, what is new?
- EFSA Guidance – what’s new?
- The transparency regulation – changes to feed additive procedures
United Kingdom and Great Britain
- Where are we now post-BREXIT?
- Recent developments
- The US FDA approach to the regulation of feed ingredients
- Legal and regulatory framework
- Authorisation pathways for feed ingredients
- Recent changes
Workshop 1: Strategic options for animal nutrition products in the EU
Workshop 2: Study design and statistics – what EFSA wants
Workshop 3: Managing dossier projects – best practices
To book the course please follow the link.
“The course was well researched, up to date and very useful. The speakers were knowledgeable and helpful.”
Simone Midori Costa
“Very dense in information, as expected. The experience of the speakers makes a lot of difference because many different examples were presented.”
Probiotics International Ltd
“A very good, informative course that was well delivered.”
“Definitely worthwhile coming.”
“Excellent presentation. Good interaction, very clear explanation.”