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CTD模块1的撰写要点和NMPA技术要求

时间: 05 月 20 日 09:00 - 10:10
日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
李玉敏
北京科林利康医学研究有限公司药政事务部工程师
Angela (Yumin) Li, Senior Vice President, Regulatory Affairs,Beijing Clinical Service Center • 30 years of Regulatory Affairs experience in the pharmaceutical industry; • Contributed herself to Merck Serono, Sanofi, and Bayer, etc. with rich experiences in CTA/NDA submission for innovative drugs; • Major therapeutic areas of innovative products for CTA/NDA submission are Oncology, Immunology, and OTC, etc.; • Successfully lead TAs of oncology and internal medicine (osteoporosis, diabetes, digest, external use, antibiotics. etc) for several Import Drug License applications and approvals; • Keep well-communication with NMPA/CDE, and relevant IDCs, established a good professional relationship with relevant stakeholders.