The design of target animal safety and efficacy studies for EFSA feed additive applications requires the use of rigorous scientific methodology as well as the application of EFSA guidance documents that specify the study duration per species, endpoints according to the feed additive functional group/ claims, and statistical analysis, among others. When an applicant fails to comply with the guidelines, without sound scientific justification, this can lead to a stop of the whole EFSA evaluation procedure whereby EFSA requests additional information (also known as a clock-stop). These studies are expensive and require a considerable amount of investment in terms of time from planning through execution and final data collection; thus getting the study design wrong can lead to a significant loss of time and money, and could alsoprevent the applicant from getting the authorisation to enter the EU market.

This webinar will cover the study design requirements that are detailed on EFSA guidelines and those that are not, as well as specific advice for handling data, performing statistical analyses, and preparing a final EFSA compliant study report. We will also share with you our tips & tricks, obtained during our almost 20 years of experience with feed additive applications, for avoiding the common pitfalls that applicants encounter during the EFSA evaluation procedure. 

Format of the webinar: 45 minutes presentation, followed by 15-20 minutes for questions & answers. 

• Safety and efficacy studies design
• How to handle raw data
• Key points to consider when performing statistical analyses 
• How to prepare an EFSA compliant study report

• Regulatory affairs Managers
• Business Development Managers
• R&D Scientists
• Product development Managers
• Project Managers
• Scientists in CROs where clients demand EFSA-compliant studies

Dr Eliana Henriquez Rodriguez 

Eliana is an Agricultural Engineer with applied experience in animal production and research. Eliana holds a MSc in Animal Breeding and Reproduction Biotechnology as well as a PhD in Agricultural and Food Science and Technology. 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.