S0403 - China Townhall: Continuous Regulatory Reformation Frosting Chinese Innovation Ecosystem for Global Health

Tue, Mar 18, 2025 · 1:30–2:40 PM CET Shanghai 1-2 Room, Congress Center Basel

About this session

In this session, we will hear from the China Regulatory Agency (NMPA) on its regulatory system innovation and modernisation, leveraging new technologies, data science, and advanced emerging regulatory science, such as the utilisation of RWE in regulatory decision-making, Cell & Gene therapy (particularly CAR-T), Orphan Drugs, Patient-Focused Drug Development, DCT, ePI and AI in drug R&D, pediatric drug development, among many other.

Programme:
- Panel Discussion — Wenhong Li, Dingheng Zhang, Lin Shi, Katrin Rupalla, Fan Zhang
- 1. Intro Slides

Speakers

Fan Zhang

Program Manager · Center for Drug Evaluation (CDE), NMPA

Panelist
Dingheng Zhang

Project Executive, Cooperation Division · CCFDIE, NMPA

Panelist
Lin Shi

Chief Medical Officer , Acting Chairman · Beijing LNKMED (Lingxun) Medicine

Panelist
Wenhong Li

Global VP, Head of Product Development China · Hoffman La-Roche

Panelist
Katrin Rupalla

Head of Global Regulatory Affairs · Johnson & Johnson (J&J) Innovative Medicine

Panelist
Jessica Liu

VP, Senior Consultant · Tigermed Consulting Co., Ltd

Chair