全新课程 | 中国药品注册法规国际课程

了解中国法规nkc币，步入中国市场，规划全球策略

Understanding China regulations for Chinese market entry

随着中国药品审评审批制度改革及中国药监部门加入ICH并成为管委会成员，大大加快了中国药品注册技术要求和国际要求的协调统一nkc币。为实现创新药同步研发与注册，推动新药加速上市，及时了解中国法规动态变化，准确把握规则要求考量重点，对于全球注册事务负责人、研发管理及项目管理者而言至关重要。

With the reform and advancement of China's drug review and approval system and China's drug regulatory authorities joining ICH thereby becoming the member of the Management Committee, the harmonization of China's drug registration technical requirements and international technical requirements has been greatly accelerated. To ensure simultaneous R&D and coordinated registration of innovative drugs, promote the accelerated launch of new drugs, keep abreast of the dynamic changes in China's regulations, and accurately grasp the key points of the rules and regulations, it is very important for the global regulatory affairs leaders, R&D management and project managers to be well informed.

结合政策趋势、市场发展以及行业需求动态，学院设立全新“ 中国药品注册法规国际课程”nkc币。课程将围绕中国药品监管和注册管理体系，包括但不限于相关政策法规、组织机构和不同政府部门职能的解读；课程将着重讲解药品注册审评审批的重要改革事项，以及探讨在全球同步研发和中国上市申请中的申报策略。

Combining policy trends, market developments and industry demands, Yeehong Business School sets up the new course “ International Program on Chinese Drug Regulations” . The program focuses on the interpretation of the drug regulatory and registration management system, relevant policies and regulations, organizations, and functions of different government departments, highlight the process and technology reform in the drug registration review and approval, as well as the application strategy in global synchronous R&D and Chinese market application.

展开全文

01

课程目标 | Objectives

熟悉中国药品监管和审评审批相关法规体系和具体技术要求

理解中国药品注册审评审批改革中的重点事项及其与 国 外监管的异同点

把握在全球同步研发与在中国上市申报策略的考量要点及注意事项

提升研发布局与申报策略制定的能力

Familiar with the drug regulatory systems, review and approvalof the relevant legal system and specific technical requirements

Understand the key issues in China's drug registration review and approval reform and the similarities and differences with foreign regulatory systems

Grasp the key points in the considerations in global simultaneous R&D and application strategy in China

Improve the ability of R&D layout and application strategy

02 适用对象 | Participants

跨国医药公司总部或海外的研发、注册、项目管理、BD等人员

中国药企的海外团队

其nkc币他愿意学习了解中国法规与注册的人员

R&D, RA, project management, BD and other personnel of multinational pharmaceutical company headquarters or overseas

Overseas teams of China pharmaceutical companies

Other people who want to learn about Chinese regulations and registration

03

学员获益 | Benefits

建立完整的中国药品监管与注册相关法规知识体系；

理解中国药品注册管理制度设计的出发点和内在逻辑；

熟悉中国药品注册管理和申请流程nkc币，以及各相关监管机构的职能；

掌握中国药品注册路径及考量要点；

提升学员制定对于在全球研发与在中国上市申报策略的能力，帮助其制定出正确、高效、合规的申报策略nkc币。

To establish a complete knowledge system of laws and regulations related to drug administration and registration in China

To understand the starting point and internal logics of the design of China's drug registration and management system

To be familiar with China's drug registration management and application process, as well as the functions of relevant regulatory bodies

To grasp the path and considerations of drug registration in China

To improve the ability to formulate application strategies in China for global R & D, and to help to formulate correct, efficient and compliant application strategies

课程设计顾问

Course Design Consultants

按姓氏拼音排序

Sort by surname pinyin

邓 婷 | Irene Deng

赛诺菲副总裁、大中华区注册事务部负责人

亦弘商学院研究员、药品注管理课程建设委员会委员

VP & Head of GRA Greater China, Sanofi

Researcher of Yeehong Business School, Member of the Curriculum Construction Committee of Global Regulatory Science Program

霍秀敏 | Xiumin Huo

亦弘商学院课程教授

原国家药品审评中心药学高级审评员

Program Professor of Yeehong Business School

Former Senior CMC reviewer, CDE, NMPA, China

邵 颖 | Ying Shao, Ph.D.

弘星相和生物科技有限公司董事长、CEO

亦弘商学院特约顾问/特聘研究员

药品注册管理课程建设委员会主任委员

Chairman & CEO, HiDiamond

Invited Counselor & Distinguished Researcher of Yeehong Business School

Chair of the Curriculum Construction Committee of Global Regulatory Science Program

苏 岭 | Ling Su, Ph.D.

礼来亚洲基金风险合伙人

亦弘商学院研究员

临床研究管理课程建设委员会主任委员

Venture partner of Lilly Asia Ventures

Researcher of Yeehong Business School

Chair of the Curriculum Construction Committee of Clinical Research Management Program

徐 宁 | Ning Xu, M.D.

再鼎医药执行副总裁

临床研究管理课程建设委员会委员

Executive Vice President, Head of Clinical Operations, Zai Lab

Member of the Curriculum Construction Committee of Clinical Research Management Program

闫小军 | Wendy Yan

百济神州高级副总裁/全球药政事务部负责人

亦弘商学院研究员、药物研发管理课程建设委员会委员

SVP, Chief Regulatory Officer, BeiGene

Researcher of Yeehong Business School, Member of the Curriculum Construction Committee of Scientific Management of Drug R&D Program

课程师资

Course Professors

按授课排序

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张明平 | Mingping Zhang

苏州瑞博生物技术股份有限公司副总经理

亦弘商学院研究员

Vice President of Ribo

Researcher of Yeehong Business School

周 明 | Ming Zhou, M.D./ Associate Professor

汉康资本投资总监

Investment Director, Hankang Equity Investment Management

李娅杰 | Yajie Li

精鼎医药亚太区研发战略咨询技术副总裁

Vice President, R&D Strategy Consulting Technology, Asia Pacific, Parexel

吴正宇 | Zero Wu

诺和诺德（中国）制药有限公司注册事务总监

亦弘商学院研究员

Regulatory Affairs Director, Novo Nordisk (China)

Researcher of Yeehong Business School

闫小军 | Wendy Yan

百济神州高级副总裁/全球药政事务部负责人

亦弘商学院研究员、药物研发管理课程建设委员会委员

SVP, Chief Regulatory Officer, BeiGene

Researcher of Yeehong Business School, Member of the Curriculum Construction Committee of Scientific Management of Drug R&D Program

课程设置 | Curriculum

时 间：2022年12月7-9日

Date: December 7-9, 2022

课程安排：共12学时nkc币，每学时45分钟，分3次授课

Course schedule：Total 12 class hours, divided into three timesnkc币，and each class hour is about 45 minutes

北京时间 21:00-24:00/每次

Beijing 21:00-24:00/each class

美东时间 8:00-11:00/每次

EST 8:00-11:00/each class

中国药品监管与政策法规体系（4学时）

The Drug Regulatory System (4 class hours)

药品管理法及实施条例/疫苗管理法/药品注册管理办法/药品生产监督管理办法

药品注册分类及药品注册申报路径

监管机构及其职能

其nkc币他相关政府部门及其职能

Q&A

The Drug Administration Law and Implementation Regulations

The Vaccine Administration

The Measures of Drug Administration Law

Measures for Supervision and Administration of Drug Production

Drug registration classification and drug registration application path

Regulatory agencies and their functions

Other relevant government departments and their functions

Q&A

药品注册审评审批改革事项（6学时）

Drug registration review and approval reform (6 class hours)

创新药四个加速审批通道：突破性治疗药物程序、附条件批准程序、优先审评审批程序、特别审批程序

临床试验改革：60天默认许可制

沟通交流：药物研发与技术审评沟通交流管理办法

MAH制度：对药品全生命周期的质量管理能力、风险控制能力、责任赔偿能力

原辅包的管理：关联审评审批

仿制药质量一致性评价：与原研药品质量和疗效一致的原则

MAH制度：对药品全生命周期的质量管理能力、风险控制能力、责任赔偿能力

原辅包的管理：关联审评审批

Four accelerated approval paths for innovative drugs: breakthrough therapy drug procedure, conditional approval procedure, priority review approval procedure, and special approval procedure

Clinical trial reform: 60-day default licensing system

Communication: Drug R&D and Technical Review Communication Management Measures

MAH system: quality management ability, risk control ability, and attorneys, insurance and other solutions for mitigating liability obligations for the whole life cycle of drugs

Management of API, excipients and packaging: related review and approval

Quality consistency evaluation of Generic drugs: the principle of consistency with the quality and efficacy of Reference Listed Drugs

全球同步研发及多国注册申报策略（2学时）

Global Simultaneous R&D and Multinational Application Strategy (2 class hours)

如何制定注册策略并选择申报国家

申报途径分析

双报或多报策略的考量

Q&A

How to develop a registration strategy and choose a reporting country

Application path analysis

Strategic considerations for simultaneous applications filing in two countries

Q&A

授课语言：英语

Teaching Language：English

申请信息：本课程每模块仅招收30名学员

Application Information：Only 30 students per module are admitted

Course Fee：1,300 USD/person or 9,000 RMB/person, including tuition fee and other related materials fee

课程费用：1,300美元/人或9,000元/人民币nkc币，包括学费及其他相关材料费

Early Birds: 1,150USD /personor 8,000 RMB/person before 10/20

早期优惠：10月20日前报名且缴费者nkc币，可享受早期报名优惠价 1,150美元或人民币8,000元

The registration channel is now open. Scan the QR code below or click "Read more" at the end of the article to register.

execed@yeehongedu.cn

相关链接：

临床研究管理专业能力培养项目第五期

药物研发管理专业能力培养项目第六期

药品注册管理专业能力培养项目第五期

药品制造管理专业能力培养项目第三期