Back to Agenda
Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing
Session Chair(s)
Imein Bousnina, PHARMD, MSC
Director, US Regulatory Policy, Product Development Regulatory
Genentech, A Member of the Roche Group, United States
This session explores the FDA and EMA’s evolving strategies to modernize nonclinical regulatory frameworks. We will examine both agency initiatives to reduce animal testing where scientifically appropriate and their roadmaps for increasing the regulatory acceptance of New Approach Methodologies (NAMs). We will discuss efforts to drive international harmonization on alternative nonclinical strategies via ICH. Participants will also gain insights into how the industry is currently integrating NAMs into submissions and broader strategies for animal testing reduction.
Learning Objective : Describe FDA's objectives under their roadmap to reducing animal testing in preclinical safety studies; Recognize EMA's ongoing activities to promote the integration of NAMs and reduce NHP studies; Discuss international harmonization via ICH; Discuss industry's experience to date with submitting NAMs in regulatory applications and overall reduction of animal testing strategies.
Speaker(s)
Modernizing Nonclinical Safety Assessment via ICH
Amanda Roache, MS
PhRMA, United States
Deputy Vice President, Science and Regulatory Advocacy
FDA Presentation on Modernizing Nonclinical Safety Assessment
Haleh Saber, PHD
FDA, United States
Deputy Director, DHOT/ OHOP/ CDER
EMA Presentation on Modernizing Nonclinical Safety Assessment
Orla Moriarty, PHD
European Medicines Agency, Netherlands
Scientific Officer
Have an account?