IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany

Yasha Huang

Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence, Roche Diagnostics

Yasha has extensive experiences in health policy and she is passionate about advocating for regulatory science as well as enhancing holistic capability building for regulatory professionals.

Prior to Roche, Yasha was most recently the Regulatory Affairs Director at APACMed. Her main role was driving regulatory initiatives for patients’ better access to medical technologies, by leading the Regulatory Affairs Committee and collaborating with key stakeholders including government agencies, local associations, regulatory harmonization and convergence platforms, such as IMDRF, AHWP, APEC RHSC, etc.

Before that, Yasha was working at the China Food and Drug Administration (CFDA), where she was actively involved in global governance and stakeholder engagement, collaborating with international organizations, government agencies, NGOs, academia, donors, and industry.

Yasha holds a Master’s Degree in Public Health from Dartmouth College, U.S. with a Fulbright scholarship. She has authored white papers and position papers on regulatory competency framework, acceptance of overseas clinical performance evaluation, regulatory agility during the pandemic, EU IVDR impact on Asia Pacific markets, etc. She was recently elected as the Vice Chair of the APACMed Regulatory Affair Committee. Prior to that, she served as Chairperson of IVD Regulatory Group and Vice Chair of Digital Health Regulatory Group under the APACMed Regulatory Affair Committee.