Bio: With over 15 years of experience in product health safety assessment and regulatory toxicology work, Dr Xiaofeng FANG is serving as the Senior Manager of Product Safety Evaluation for the Asia-Pacific region at L'Oréal Innovation and Research Center, primarily engaged in safety assessment in the fields of cosmetic ingredients and products, beauty devices, and medical devices. Dr. FANG is a standing Committee Member of the Management Toxicology and Risk Assessment Professional Committee of the Chinese Society of Toxicology, a Diplomate of the American Board of Toxicology (DABT), a European Registered Toxicologist (ERT), and a Chinese Certified Toxicologist (DCST).  His toxicological expertise spans new chemical substances, agricultural chemicals, medical devices, food contact materials, and packaging materials. Additionally, the individual is well-versed in nonclinical safety evaluation and GLP (Good Laboratory Practice) system, with many years of professional experience in these areas.

Abstract: Integrated Approaches to Testing and Assessment (IATA) are flexible, science-based approaches for chemical safety assessment that rely on an integrated analysis of existing information coupled with the generation of new information using testing strategies. IATA can include a combination of methods. In addition to traditional in vitro and in vivo tests, it can incorporate new approach methodologies (NAMs). IATA can be informed by integrating results from one or many methodological approaches [(Q)SAR, read-across, in chemico, in vitro, ex vivo, in vivo] or omic technologies (e.g. toxicogenomics).

With the evolution of IATA in the application in toxicology, a clear distinction between rule-based approaches that generate predictions, termed “defined approaches” (DA) to testing and assessment, and flexible, judgement-based approaches that lead to safety conclusions have been introduced in the IATA guidelines. Increasingly IATAs are based on methods that measure or predict Key Events in Adverse Outcome Pathways (AOPs) relevant to the biological effect of interest. The Adverse Outcome Pathway (AOP) concept can be applied as a framework to develop IATA. The application of IATA follows an iterative approach to answer a defined question in a specific regulatory context, taking into account the acceptable level of uncertainty associated with the decision context.