Recent Trends in the Regulation of Biopharmaceutical Products - English

Every regulatory agency around the world has been addressing the emergent issues for the last two years and they may evolve through the lessons learned from the unprecedent situation. In this opening scientific session, an international group of regulators will provide the recent regulatory updates and future perspective on the regulation of biopharmaceutical products. The presentations will include information that will contribute to, and be further explored in, panel discussions covering several themes, including:
Preliminary Key Questions:
1. Regulatory update on biopharmaceutical products.
2. Hot topics of CMC review / GMP inspection on biopharmaceutical products.
3. Lessons learned from COVID-19 pandemic and future initiatives.
4. Operation status and points to consider for accelerated approval program.
5. Prospect and possibility for further international collaboration in CMC department.
6. Global procurement risks of raw materials for biopharmaceutical products and accompanying regulatory treatment

Session Speakers:
09:35 - 10:00
Regulatory Updates and a Perspective on Biopharmaceuticals in Japan
Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency, Japan

10:00 - 10:25
China's Regulatory Framework for Biological Products and the Latest Trend
Min Li, Center for Drug Evaluation (CDE) of NMPA, China

10:40 - 11:05
Regulatory Considerations for Moving from Emergency Use Authorization to Biological License Application for U.S. Products
Robin Levis, CBER, FDA, United States

11:05 - 11:30
FDA Perspective on Opportunities for Modernization of Regulatory Submissions
Ingrid Markovic, CBER, FDA, United States

11:30 - 11:55
EMA’s Support to Innovation – A Status Update
Veronika Jekerle, European Medicines Agency, Netherlands