Dr. Hong Yang is a senior advisor on Benefit-Risk in the Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration. She was a member of FDA Benefit-Risk Guidance Working Group and FDA Benefit-Risk Framework Implementation team. She led many benefit-risk assessments to inform regulatory decision in CBER. She currently actively participates and contributes to CIOMS (COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES) Working Group XII for Benefit-Risk Balance for Medicinal Products, and the BRAP (Benefit-Risk Assessment Plan) and the BRATS (Benefit-Risk Assessment Tool Suite) Taskforces of ASA Safety Evaluation Working Group.