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Date Time 18:30 - 20:00
Location Webinar Timezone Asia/Shanghai
As Chinese biopharmaceutical companies increasingly pursue approvals in Europe and the United States, regulatory success depends on far more than generating positive clinical data.
This webinar, comprising a presentation, panel discussion and Q&A, will explore the key challenges that can limit the global acceptability of China-origin development programs, including regulatory pathway selection, clinical trial design, data integrity, manufacturing readiness, and regional operational requirements.
The session will examine why a "global-by-design" approach, incorporating early regulatory engagement, multi-regional development strategies, and inspection-ready evidence generation, is becoming increasingly important. Attendees will gain insights into building development programs that meet both EU and US expectations, anticipating regulatory pitfalls and understanding how product differentiation, regional applicability and evidentiary standards may influence the likelihood of global regulatory success.
Panelists
Cheng Chen, Manager, Regulatory Strategy, ICON plc
Guoying Tan, Director of International Regulatory Affairs, HEC Pharma
Shizhong Luo, Founding Partner, Anjin Healthcare Globalization Alliance & Innovation Center (Moderator)