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#516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing
Tuesday June 16, 2026 10:15am - 11:30am EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-563-L04-P; CME 1.25; RN 1.25

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 Objectives

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.

Chair

Imein Bousnina, PHARMD, MSC

Speaker

FDA Presentation on Modernizing Nonclinical Safety Assessment
Haleh Saber, PHD

Modernizing Nonclinical Safety Assessment via ICH
Amanda Roache, MS

EMA Presentation on Modernizing Nonclinical Safety Assessment
Orla Moriarty, PHD


Speakers
avatar for Imein Bousnina

Imein Bousnina

Director, US Regulatory Policy, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Over her decade at Roche-Genentech, she has served as a subject matter expert and led the implementation of regulatory policy strategies on topics such as FDA and EMA's regulation... Read More →
avatar for Orla Moriarty

Orla Moriarty

Scientific Officer, European Medicines Agency, Netherlands
Orla Moriarty is a scientific officer in the Translational Sciences Office at EMA where she is responsible for providing scientific support to the Agency’s 3Rs and Non-clinical Working Parties. She joined EMA in 2023 as a Seconded National Expert from the Irish Health Products Regulatory... Read More →
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
HS

Haleh Saber

Deputy Director, DHOT/ OHOP/ CDER, FDA, United States
Dr. Saber is the Deputy Director in the Division of Hematology Oncology Toxicology (DHOT). In this role, she provides leadership for day-to-day activities, leads and coordinates scientific research, and participates in guidance development. Dr. Saber has extensive industry and regulatory... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Preclinical & Early Phase Research,Regulatory
  • Tags Forum

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