第三届全球(长春)制造业服务外包峰会
杨东
徕博科(科文斯)医药研发(北京)有限公司中国法规事务部负责人
杨东博士是徕博科(科文斯)中国的法规事务部的负责人,在新药开发方面有超过15年的专业经验,支持IND和NDA申报的研发项目和法规事务工作。
他获得全球法规事务专业委员会(RAPS)认证,现在徕博科(科文斯)中国主持所有注册相关事务,并为内部和外部客户提供法规注册策略,包括进行差距分析,与客户和监管机构合作组织和准备临床开发计划、与监管部门及KOL沟通交流、IND和NDA注册提交、人类遗传资源管理行政许可申请及进出口申报等。
杨博士还在美国和中国获得毒理学家(DABT和DCST)认证,拥有超过10年在CRO和研究机构规划和开展支持IND和NDA申报的新药研究项目的实践经验。同时,他在处理美国FDA、OECD和NMPA检查员的现场核查方面有多年的经验。
Dong YANG
Head of Regulatory Affairs at Labcorp (Covance) China
Dr. Dong Yang is the Head of Regulatory Affairs at Labcorp( Covance) China, and has over 15 years of professional experience in drug development to support IND/NDA-enabling projects and Regulatory Affairs.
As a board certified Regulatory Affairs Professional (RAC global), Dr. Yang leads the regulatory relevant activities and provides strategic regulatory input for internal and external customers, including performing gap analysis and working with clients and Regulatory Agencies in the organization and preparation of clinical development plans, Agency interactions and KOL engagements, IND and NDA applications, HGRAC submissions, and CIQ applicaitons.
As a US and China board-certified toxicologist (DABT and DCST), Dr. Yang has more than 10 years of hands-on experience in planning, conducting, and overseeing IND- and NDA-enabling GLP compliance studies/projects in CROs and researches in institutions. Meanwhile, he has years of experience on handling on-site regulatory inspections by US FDA, OECD, and NMPA Inspectors.