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孫志剛博士現(xiàn)任綠葉制藥集團(tuán)高級副總裁，負(fù)責(zé)整個(gè)集團(tuán)的國際研發(fā)、全球質(zhì)量、和全球藥物警戒等方面的工作。 他也曾在美國擔(dān)任太陽藥業(yè)有限公司監(jiān)管事務(wù)副總裁，負(fù)責(zé)新藥和仿制藥的上市注冊申報(bào)及上市后變更管理工作。 加入工業(yè)界之前，孫博士曾在美國FDA工作近12年，擔(dān)任工藝設(shè)施辦公室（OPF）工藝評審II處代理主任，主要負(fù)責(zé)新藥和仿制藥的質(zhì)量審評和批準(zhǔn)前檢查（PAI）。他還擔(dān)任過FDA仿制藥辦公室（OGD）CMC審評組組長以及FDA駐華辦公室（北京）代理藥品助理主任。除藥物質(zhì)量審評和GMP現(xiàn)場檢查外，孫博士也應(yīng)邀加入多個(gè)FDA技術(shù)委員會，參與制定藥物審評的內(nèi)部政策程序及外部企業(yè)指南， 并多次獲得FDA獎勵。目前他應(yīng)邀擔(dān)任2020-2025界美國藥典委員會委員（USP Expert Committee）和專家組（USP Expert Panel）成員, 以及中國醫(yī)藥創(chuàng)新促進(jìn)會國際創(chuàng)新藥物監(jiān)管專業(yè)委員會委員。

Dr. Zhigang Sun is currently Senior Vice President at Luye Pharma Group Ltd.，responsible for international R&D, global quality, and global pharmacovigilance. He previously served as Vice President of Regulatory Affairs at Sun Pharmaceutical Industries, Inc. in the United States, where he was responsible for the marketing registration and post-market change management of new drugs and generic drugs. Prior to joining industry, Dr. Sun worked at U.S. FDA for nearly 12 years, where he served as the acting Branch Chief at Office of Process and Facilities (OPF), and was responsible for? quality review and pre-approval inspection (PAI) of new drugs and generic drugs. He also served as the CMC team Leader at Office of Generic Drugs (OGD), FDA, and the acting Assistant Country Director for Drugs at FDA China Office (Beijing).? In addition to drug review and CGMP inspection, Dr. Sun involved in developing CDER Manual of Policies and Procedures (MaPP) and FDA Guidance for Industry in several FDA technique committees, and has been awarded many times within the FDA owing to his excellent contribution.? He is currently invited to serve as a member of the USP Expert Committee and a member of the USP Expert Panel in 2020-2025, as well as a member of the International Innovative Drug Regulatory Committee of the China Association for the Promotion of Pharmaceutical Innovation.