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『国際共同治験における各国とのRegulation ～CFDA～』 講演者：Gao Yang Principal Consultant PAREXEL Consulting - Beijing, China  【講演者プロフィール】 ◆EXPERIENCE 2005～2013 CMC reviewer at CDE of CFDA 2013～2017 Eli Lily China RA CMC & Device Head 2015 Chairman in RDPAC CMC Council 2017～2018 RA Director in Ascentage Pharm 2018～ Principal Consultant in PAREXEL ◆EDUCATION & TRAINING Ph.D., PKPD, China Pharmaceutical University Master, Pharmaceutical Science, China Pharmaceutical University Bachelor, Pharmacy, Shandong Medical University ◆EXPERTISE CMC & BE : profound understanding of both ICH and China regulatory CMC requirements, with rich hands-on experience of dossier reviewing, gap analysis and problems solving for IND, NDA, ANDA and Supplementary applications. General regulatory affairs : comprehensive understanding of China regulatory system. Hands-on experience to manage the whole process of preparing, submitting and maintaining the regulatory applications and documents. Hands-on experience to develop a global regulatory plan with integrating R&D and business plans. |
