姜婧

辉瑞研发亚太注册说明书中心药品注册说明书高级经理

Work History: Jul.2012 – Present Sr. Hub Labeling Manager, Pfizer (China) R&D Center - Established and impelled the new Hub business model in Asia as a key member, and built up win-win collaboration with local regulatory team; liaised with global roles (incl. regulatory, safety), to ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders Sep.2011 – Jul.2012 China Regulatory Operation, Bayer Healthcare - Timely supported the high-priority regulatory projects in China across multiple Therapeutic Areas, IMCT, Labeling/CMC variation - Collected the RA intelligence on the related guidelines and business Aug.2009 – Sep.2011 Global Labeling Specialist, Global R&D Center, Bayer Healthcare - Mainly responsible for creation and update of Company Core Data Sheet (CCDS) on labeling perspective, for Women’s Healthcare products at a global level; Educational History: M. SC, Biochemistry Tsinghua University Publication: Lu F, Li S, Jiang Y, Jiang J, et al. Structure and mechanism of the uracil transporter UraA. Nature 2011; 472: 243–246

木村亮太　

PMDA医薬品安全対策第一部审评员

Academic history: 2011 March M.D. in Graduate School of Pharmaceutical Sciences, Chiba University Employment history: 2019 January - now Reviewer, Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency 2018 January - 2018 December Reviewer, Office of Safety II, Pharmaceuticals and Medical Devices Agency 2015 October - 2017 December Assistant manager, Pharmacovigilance Department, EPS Corporation. 2011 April – 2015 September Staff, Pharmacovigilance Department, EPS Corporation.

松井理惠

辉瑞（日本）国际说明书团队亚太区负责人

Rie Matsui is currently Director, Regional Labeling Head for APAC, International Labeling Group, Worldwide Safety & Regulatory, Pfizer Japan. She is the founder of Asia Labeling Hub at Pfizer which was established in July 2012. The Asia Labeling Hub has created various local label updates for more than 25 countries in Asia ever since its launch and she works with 15 affiliates in Asia. She has been a member of the Advisory Council of DIA Japan. She won the DIA Japan regional award in 2015. She has been actively involved in a number of conferences in Japan, China, Singapore and the U.S., both as a session chair and speaker. Her paper has been recently published in “Therapeutic Innovation & Regulatory Science”.

王闻雅

清华大学药品监管科学研究院研究员

杨晓燕

百济神州药物警戒和药物安全资深总监