DIA全球首席执行官巴巴拉·昆茨及2022 DIA中国年会联席主席闫小军共邀您参加中国国际药物信息大会/2022 DIA中国年会

2022 DIA年会暨展览会

Welcome to Suzhou and to our DIA China Annual Meeting 2022. Thank you for joining us to share your experiences and create momentum to move clinical research and therapeutic product development forward here in China and around the world.

This China Annual Meeting marks the end of a long and often complicated journey through the challenges of the COVID-19 pandemic and its restrictions, and DIA is profoundly grateful to the China Center for Food and Drug International Exchange (CCFDIE), our co-host. Thank you to all who worked on the Program Steering Committee, International Advisory Committee, and Program Committee to create this opportunity.

WealsosincerelythanktheInternationalCouncilforHarmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE) in China, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the European Medicines Agency, the US Food & Drug Administration, our DIA China network of volunteers and staff, and the numerous other organizations whose members have contributed their thought leadership to building this event.

The pandemic may have changed certain circumstances in which we convene but not the purpose for which we come together. Through it all, our program committee has organized our DIA China Annual Meeting 2022 along the theme Innovation to Protect Health, Collaboration to Lead the Future. Over the next few days, you’ll see various aspects of this program bring the ideas of innovation, collaboration, and the future to life.

In the Global Regulatory Modernization Townhall, representatives from the NMPA, PMDA, EMA, and US FDA will share the lessons they learned together from their regulatory response to COVID-19 and how these lessons will ensure more innovative drug regulation in the future. The Japan Pharmaceutical Manufacturers Association will join PMDA for another session on these innovations. We will explore innovative new targets and new therapies on the cutting edge of science in oncology and other therapeutic areas through the Innovative Drug Development program theme.

DIA China 2022 will open with the now traditional ICH Day, which we have collaboratively presented with the International Council for Harmonisation since DIA China 2018. This 2022 offering will summarize regulatory progress made since China became a full ICH member in 2017 and the direction and significance of the ICH-related work planned in China over the next five to ten years. In another special collaborative session, EMA, FDA, and PMDA will share their experiences in accelerated review and conditional approval under China’s new drug regulations with the audience.

DIA China 2022 will also present new research into drug regulation in China in the China Regulatory Science in Action Symposium co-organized with the Pharmaceutical Regulatory Research Association.

And throughout the meeting, twelve DIA China Communities will host Engage and Exchange sessions that provide additional opportunities for you to collaborate on ideas with colleagues who work in your professional discipline or share your professional interests.

As for the future, this year’s program also features a special Pediatric Drug Development Forum presented in conjunction with the CDE, NMPA. This Forum will address the needs of pediatric drugdevelopment from the perspective of scientific, industry, and regulatory practice and innovation. Adopting scientifically feasible methods that ensure the integrity of data generated in pediatric clinical trialswhile protecting the children in these trials will simultaneously ensure a better and healthier future for our children.

All these highlights and more are waiting for you to discover them in our next few days together.

On behalf of our staff and volunteer network who have worked to organize and present it, and on behalf of the patients in China and all around the world whom we work together to serve, thank you for your commitment to better health, for your resilience, and for choosing to attend our DIA China Annual Meeting 2022.

尊敬的业界各位同仁们、各位专家、女士们、先生们;

首先，请允许我代表大会组委会，欢迎大家来到风景秀丽的苏州，参加2022中国国际药物信息大会/2022DIA年会。

新冠疫情凸显了医药产业作为健康守护者的角色，而产业层面，不管是监管机构还是行业发展，合作已经是国际化语境中的新常态。2022年DIA会议的主题是“创新守护健康，合作引领未来”，就是将产业热点、行业趋势、监管新动态等贯穿起来后，总结概况的关键词。

DIA大会从最早的上千人，到现在的接近万人规模，可以看到产业界对监管科学助益产业创新，用国际化视野认知自身所在领域的学习迫切性。在国际化目标下，DIA每年的议题设置也是尽可能地在全球视野下，将创新研发整个链条上的利益相关者，在这个中立的平台上，进行自由和跨国界的交流分享，在这里，你能看到所有研发产业链上全景生态的人，可以接触并分享研发产业链上全景生态的相关知识。

今年，DIA会议产业层面的话题依然亮点纷呈。在监管科学和临床相关的议程上，除了聚焦行业中讨论声音最多的中国新法规下如何加快审评、附条件批准、以临床价值为导向的新药研发、MAH在中国实施的挑战等热点话题外，还包括非肿瘤药物、肿瘤药物及新靶点、新技术药物临床开发的最新进展；以患者为中心的临床运营、质量管理以及临床药品管理、CMC、非临床开发、药物安全和药物警戒、生物统计和数据管理等13大专题内容。此外，针对儿童临床研究困境这一全球性难题，本届大会专门开辟儿科用药专题会场，关注儿童药物开发需求，旨在从监管政策及工业界创新角度不断地探索实践，致力于采用科学可行的方法，保障儿童用药信息的完整、可靠，同时尽可能保护儿童在试验中的安全，确保良好的研究质量。

从制药大国到制药强国，在不断完善的监管生态下，需要代表产业创新的各个环节共同努力，共享智慧与洞察。DIA中国年会将持续不断，为中国药企国际化打造一个客观、中立、共享的产业沟通平台。相信本次大会将为中国和全球药物创新带来更加积极的影响。

期待与业界同仁云端相见！