Biologist
FDA/CBER/OBPV, United States
Dr. Hong Yang is a senior advisor on Benefit-Risk in the Office of Biostatistics and Pharmacovigilance, CBER, FDA. Dr. Yang has more than 25 years-experience in computational modeling and simulation, especially its application in risk assessment and benefit-risk assessment. Dr. Yang has led many quatitiative risk assessments and benefit-risk assessments to inform FDA regultory review and guidance for drugs and biologics including multiple benefit-risk assessment for COVID-19 vaccines. She has been an active member of multiple national and international benefit-risk assessment working groups (FDA Benefit-Risk Working Group, COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES Working Group XII-Benefit-Risk Balance for Medicianal Products, American Statistical Association Benefit-Risk Assessment Planning and Benefit-Risk Assessment Tool Suite Working Teams, and ISPE BRACE SIG).
Disclosure information not submitted.
Benefit-Risk Assessment to Support the FDA’s Decision on Vaccines for SARS-CoV-2
Sunday, August 27, 2023
1:30 PM – 1:45 PM ADT
