2016药物研发定量科学论坛

中国临床试验生物统计学组

中国临床试验数据管理学组

DIAChina

50 多年来，DIA（药物信息协会）一直是医疗保健产品研发和生命周期管理专业人员的全球性论坛，在中立的环境中交流知识和合作。DIA 提供的重要资源，让人们有机会拓展辩论和讨论的范围，推进科学和医学创新。

内容概览 (Overview)

自2013年起，药物信息协会（DIA）成功举办了三届药物研发定量科学论坛，为国内外相关领域的专家、学者、同行提供了一个跨学科的共同探讨药物研发中和定量科学相关课题的讨论平台。2016年DIA将与中国临床试验生物统计学组（CCTS）和中国临床试验数据管理学组（CDMC）联合举办第四届药物研发定量科学论坛。近年来，定量决策与法规科学的长足发展显而易见，ICH经历了重大变革，并且建立了多个工作小组，包括ICHE6（GCP）、E9（统计）、M4E（CTD有效性与效益风险）的修订以及ICHE17新指南（多区域临床试验）。在中国，CFDA发布了MRCT新指南和中国临床试验生物统计学指导原则。在加强临床试验数据自查核查、提高质量的环境下，本届论坛以“定量科学与新法规指南”为主题，详细解读新法规指南，探讨为合格和优秀的临床试验提供科学规范的统计与完整有效的高质量数据管理等定量科学问题。来自监管机构、统计学界以及中国临床试验生物统计学组（CCTS）的专家将参与讨论，与参会者分享定量科学相关知识和经验。

Since 2013, DIA China held 3 editions of Quantitative Science Forum, which were successful event series that provided a multi-functional forum within China to discuss quantitative science topics in pharmaceutical product development. The DIA China, China Clinical Trial Statistics (CCTS), and Clinical Data Management working group of China (CDMC) Working Group will co-host the 4th “DIA China Quantitative Science Forum" in August 2016 again. In the last few years, we have seen significant advance in quantitative decision making and regulatory sciences. Globally, ICH has gone through a significant reform and has established multiple working groups including the revision of the ICH E6 (GCP), E9 (Statistics), M4E (CTD efficacy and benefit-risk), and new guidance ICH E17 (multiple regional clinical trial). In China, CFDA also issued a new guidance on MRCT and a revised draft guidance on statistics principle. Nowadays, the Chinese industry faces greatly severe test on clinical trial data self-inspection and audit. The 2016 forum, with the theme of “Quantitative Sciences and New Regulatory Guidance”, will interpret the new regulatory guidance and share knowledge of quantitative issues in safety, efficacy, risk- benefit, and potentially cost-effective utilization to provide scientific and standardized statistics for the qualified or excellent clinical trials, as well as how to provide complete, effective data with high quality. Dedicated sessions featuring consensus from the key statistics opinion leaders and experts from CCTS will be presented to the participants.

学习内容 (Learning Objectives)