CEd-Tox: Continuing Education Courses Online

An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions

SOT Virtual CE Course: PM13

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Chair(s): Mansi Krishan, Danone North America; and Suzanne Fitzpatrick, US FDA/CFSAN.

Primary Endorser:
Risk Assessment Specialty Section

Other Endorser(s):
Drug Discovery Toxicology Specialty Section

Recent shifts in the global regulatory landscape to consider the use of nonanimal testing methods have led to significant advances in the development of alternative test methods to replace, reduce, and refine animal use. The term new approach methodologies (NAMs) broadly describes any nonanimal technology, methodology, approach, or combination that can be used to provide information on chemical hazard and risk assessment. With new opportunities comes new challenges, such as validation of test results, understanding their applicability in different sectors and risk assessments, and global regulatory acceptance of these methods. Despite these challenges, the development, use, and acceptance of these predictive toxicology methods is on the rise. There is a wealth of knowledge and data that is being generated with NAMs; however, there are questions on when, how, and where can we use these NAMs. This CE course will provide an overview of NAMs along with case studies where they are being used or could potentially be used for regulatory risk assessment. The speakers will present on (1) chemical-biological data and analysis tools (Tox21/ToxCast) and examples where high-throughput screening (HTS) methods have been approved for use in regulatory decision-making; (2) read-across approaches and their use in regulatory risk assessment; (3) use of evidence maps and systematic reviews and case studies with a focus on application of each to regulatory risk assessment; (4) use of the adverse outcome pathway (AOP) including most well-developed examples of AOP-supported decision processes for evaluating skin sensitizing potential and a computational model to predict the likelihood of reproductive impairment based on aromatase inhibition; and (5) concepts underpinning Integrated Approaches to Testing and Assessment (IATA) and concrete examples for assessing developmental neurotoxicity (DNT) and carcinogenicity of chemicals used in a variety of sectors. Also, updates will be provided on IATA case study projects currently running at the OECD and a set of resources being developed to support IATA development, evaluation, and regulatory uptake. This course will be useful to those interested in understanding the regulatory application of NAMs.

  • An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions

    Chemical Bioactivity Data and Useful Analysis Tools for You to ExploreN. Sipes. NIEHS/NTP, Durham, NC.

    Building Confidence in Read-Across Conclusions with NAMsC. Rowlands. Underwriters Laboratories R&D, Northbrook, IL.

    Systematic Reviews: Application in Regulatory Risk Assessment.—K. Thayer. US EPA, Research Triangle Park, NC. Sponsor: M. Krishan

    The Adverse Outcome Pathway (AOP) and Its Use to Support Regulatory Risk Assessment.C. Willett. Humane Society International, Jamaica Plain, MA.

    Overview and Case Studies to Demonstrate the Use of Integrated Approaches to Testing and Assessment (IATA) in Regulatory Risk Assessment.—M. Whelan. European Commission Joint Research Centre, Ispra, Italy. Sponsor: M. Krishan

Certificates

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