SOT FDA Colloquia: IATA – The Future of Regulatory Toxicology Assessment

Online - Live Webcast
28th May 2020

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This colloquium – co-chaired by AFSA Tox21 workstream lead Lidia Ceriani – will feature an emerging flexible approach to evaluating and generating information to meet different regulatory purposes by means of Integrated Approaches to Testing and Assessment (IATA). IATAs are pragmatic, science-based frameworks for chemical hazard or risk characterization, which follow an iterative, integrative approach to answer a defined question with the required certainty in a specific regulatory context. Development of an IATA begins with problem formulation: the context of the decision and taking into account the overall risk management goals. Different types of information from existing sources, new testing (e.g., in chemico, in vitro, and in vivo), and non-testing (e.g., in silico), can be considered as needed, potentially using Integrated or Sequential Testing Strategies (ITS/STS) and evaluated using Weight of Evidence in an iterative process. IATA can be supported by Adverse Outcome Pathways (AOPs) that can inform hypothesis generation, weight of evidence analysis, and choice of assays for integrated assessment.

This session will introduce the concept, process, and components that comprise an IATA and present several case studies demonstrating different applications of this decision tool. Issues, challenges, and prospects of adopting IATAs in regulatory risk assessment will be discussed.

Note: All times are in Eastern Daylight Time (EDT)

8:30 AM–8:40 AM
Welcome and Speaker Introductions
Suzanne Fitzpatrick, Colloquium Co-chair, US FDA CFSAN, College Park, MD

8:40 AM–8:55 AM
Integrated Approaches to Testing and Assessment (IATA)–An Introduction
Lidia Ceriani, Humane Society International / AFSA Collaboration, Belgium/Italy

8:55 AM–9:15 AM
Uncertainty Characterisation in IATA for Chemical Safety Assessment: Overview of Available Guidance
Andrea-Nicole Richarz, ECHA, Helsinki, Finland

9:15 AM–9:50 AM
Learnings and Recommendations from Four EU-ToxRisk Case Studies on Applying New Approach Methodologies Data to Support Read-Across
Susanne Hougaard Bennekou, Technical University of Denmark, Copenhagen, Denmark

9:50 AM–10:25 AM
IATA as an Opportunity for Next-Generation Risk Assessment: The Propyl Paraben Case Study
Gladys Ouédraogo, L’Oréal, Paris, France

10:25 AM–11:00 AM
Global Harmonization Efforts for Skin Sensitization IATA
Nicole Kleinstreuer, NICEATM, Durham, NC

11:00 AM–11:35 AM
Applications of New Multi-Organ-Chip Tools for Toxicity Assessment
Reyk Horland, TissUse GmbH, Berlin, Germany

11:35 AM–12:35 PM
Roundtable Discussion
Moderator: Lidia Ceriani / All Speakers