Forum Agenda

July 23,13:30-17:30

IIT Supervision Model and China’s Innovation Efficiency Session

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Meeting Planning
Jie Li:Senior Vice President, Regulatory Affairs, Aeira Health; Director, All-Chain Pharmaceutical Information Research Institute, Beijing Economic-Technological Development Area
Dan Zhang:Foreign Member, Russian Academy of Engineering; Chief Scientist, PUMC Innovation Port; Professor & Chief Medical Officer, Fudan Institute of Clinical Science; Co-Chairman, Hillgene Biopharma


13:30-13:40 Opening Address
Leader of the Administrative Committee of Zhengzhou Airport Economy Zone

 

13:40-14:00   Gene Editing and Cell Therapies
Mingyao Liu:Director, Shanghai Key Laboratory of Regulatory Biology; Director, Institute of Biomedical Sciences, East China Normal University; Chairman, BRL Medicine


14:00-14:20   IITs and China's Clinical Research Regulatory Pathway
Chenyan Gao:Lead Scientist, Beijing Changping Laboratory; Former Division Director, Biological Products Clinical Division, Center for Drug Evaluation, NMPA


14:20-14:40   Reflections on Clinical Research in Cellular Gene Therapy in the Context of Regulations 818 and 828
Jinping Xie:Associate Professor, Institute of Regulatory Science for Medical Products, China Pharmaceutical University


14:40-15:00   Protecting Participant Rights in IITs and Registered Clinical Research
Wenlin Huang:Chairman, Doublle Bioproduct

 

15:00-15:20 The New Hub for the CGT Industry: Zhengzhou Airport Economy Zone, Henan-CGT Industrial Park, Zhongyuan Medical Science City


15:20-15:40   Tea break


15:40-16:10   Dialogue: Global Innovation Partnerships Built on China's IIT Research
Guest: Dan Zhang:Foreign Member, Russian Academy of Engineering; Chief Scientist, PUMC Innovation Port; Professor & Chief Medical Officer, Fudan Institute of Clinical Science; Co-Chairman, Hillgene Biopharma
Interview: Fangfang Zhu:CEO, HemaCell


16:10-16:25   Pharmaceutical Research Requirements for Registered Clinical Studies of Somatic Cell and Gene Therapy Technologies
Jing Chen:Deputy Director, Regulatory Affairs


16:25-16:40   IIT Regulation in Transition: Recent Updates and Compliance Priorities
Tingting Liu:Partner, Life Sciences & Healthcare Practice, AllBright Law Offices, Shanghai


16:40-17:30   Roundtable: Maximizing China's Innovation Efficiency Through the IIT Pathway