SOT FDA Colloquium May 28: “Integrated Approaches to Testing and Assessment: The Future of Regulatory Toxicology Assessment”

May 28 Webcast.pngSOT and the US Food and Drug Administration Center for Food Safety and Applied Nutrition (US FDA/CFSAN) cordially invite you to join us for our May 28 colloquium, “Integrated Approaches to Testing and Assessment: The Future of Regulatory Toxicology Assessment.” There is no charge for this webcast. These colloquia are an update on toxicological science rather than a public forum for discussion of toxicology regulatory issues. The Chair of the colloquium is Lidia Ceriani, MSc, Humane Society International, and the Co-Chair is Suzanne C. Fitzpatrick, PhD, DABT, US FDA/CFSAN.

This colloquium 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 (IATAs). 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 compose 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.

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Schedule (all times are Eastern US, UTC-4):

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, Brussels, Belgium

8:55 AM–9:15 AM

Uncertainty Characterization in IATA for Chemical Risk Assessment
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 

Questions concerning the regulatory science for the roundtable discussion are encouraged from webcast participants. Regulatory policy will not be discussed.

The SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety present scientific training that is high-quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost.

This event will be preceded by the colloquium on April 29, “Artificial Intelligence Applications in Food and Cosmetic Safety.” Register here for this session.

Recordings and slides from the previous colloquia are available for free on the “SOT FDA Colloquia” web page, including the February 19, 2020, session, “Route-to-Route Extrapolation in the 21st Century.” Two colloquia will be developed for webcast in the next year.

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