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:
- Regulatory affairs
- Product development
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
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
Writing and managing the dossier
Final discussion, questions and answers
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.