Practical course on EU feed additive registration

Posted 17 February, 2017

Pen & Tec will deliver a comprehensive introduction to the entire regulatory dossier submission process for approval of a feed additive in the EU. Participants will gain an understanding of the requirements and necessary steps to obtain a marketing authorisation and will also learn how to avoid delays and speed up time to market.

Presentations will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different types of feed additives.

The programme includes an interactive workshop session devoted to working on case studies.

Course objectives and areas covered are:

  • EU regulatory framework – relevant legislation
  • Types of feed additives and acceptable claims
  • Data required – product characterisation, safety, quality and efficacy
  • EC, EURL and EFSA guidelines and guidance documents
  • Conducting strategic data audit and gap analyses, managing EU registration projects and writing successful feed additive dossiers
  • Post-submission hurdles – dossier validation and EFSA clock-stops

This course is suitable for managers in regulatory affairs, marketing, R&D and product development areas, as well as for CROs, scientists and those seeking to review specific issues encountered during the registration process.

Participants will receive a certificate of attendance for professional development.

The expert speakers for this event will be Dr Elinor McCartney, Pen & Tec President and Laura Payo Lewis, Pen & Tec Regulatory Affairs Director.

For more information about the course, registration and complete programme click here.