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NAMs in Regulatory Toxicology: Challenges & Considerations

In this webinar, hosted on April 8, 2026, explore how to bring NAMs into regulatory toxicology:

Key Topics:

  • Global regulatory landscape: FDA, EMA & international initiatives
  • Key terminology: Context of Use, test systems & qualification
  • Common barriers to NAM adoption and how to overcome them
  • Case studies: organoids & organ-on-chip models in toxicology
  • What builds regulatory confidence in advanced in vitro models

As regulatory agencies continue to support the use of new approach methodologies (NAMs), understanding how these technologies can be successfully implemented within regulatory toxicology has become increasingly important. In this webinar, Dr. Clive Roper explores the evolving global regulatory landscape, clarifies key terminology (e.g. distinguishing test systems from test methods, and validation from qualification), and examines the scientific and practical considerations involved in qualifying and adopting NAMs for drug development and safety assessment.

The session discusses how defining an appropriate context of use, establishing scientific confidence, and selecting fit-for-purpose in vitro models are critical to successful regulatory acceptance. Through practical case studies in respiratory and dermal toxicology, including air-liquid interface (ALI) models and complex in vitro test systems, the webinar demonstrates how advanced cell culture models, organoids, organ-on-chip technologies, and computational approaches are being applied to answer specific regulatory questions while improving human relevance. It also addresses common barriers to adoption, including validation, standardization, regulatory expectations, and benchmarking, and highlights recent initiatives from organizations such as the FDA, EMA, OECD, 3RsC and NC3Rs that are accelerating the integration of NAMs into regulatory decision-making.

Key Topics:

  • The evolving global regulatory landscape for NAMs, including recent FDA, EMA, and international initiatives
  • Defining regulatory Context of Use (CoU) and why it is essential to define model boundaries for qualification and acceptance
  • Understanding key NAM terminology, including test systems, test methods, validation, and qualification
  • Scientific confidence, reproducibility, and fit-for-purpose model selection for regulatory applications
  • Common barriers to NAM adoption and strategies to overcome scientific, technical, regulatory, and cultural challenges
  • Practical applications of organoids, organ-on-chip technologies, and other advanced in vitro models in toxicology
  • Case studies demonstrating human-relevant approaches for respiratory safety assessment and broader pharmaceutical development

Speaker Biography

Clive Roper, PhD
Director, Roper Toxicology Consulting Limited

Clive graduated with a PhD (in vitro dermal absorption, 1994) before taking a post-doctoral position (human nutrition). In 1996, he joined CRL performing in vitro skin penetration studies and was promoted to Director, In Vitro Toxicology, leading a diverse in vitro testing services portfolio. In 2021, Clive started a consulting business aiding clients in gaining adoption and regulatory acceptance of NAMs. Clive is Chairperson of PeptiMatrix, a board member of 3RsC, NC3Rs, and ESTIV (VP), a member of the Roundtable of Toxicology Consultants and Society of Toxicology, a European Registered Toxicologist, and a chartered Fellow of the Royal Society of Biology.

Publish Date: June 15, 2026

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