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1、http:/2016 药物研发定量科学论坛内容概览 (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
2、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
3、 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 Quantitat
4、ive Science Forum in August 2016 again. In the last few http:/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), E
5、9 (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 In China, CFDA also issued a new guidance on MRCT and a revised draft guidance on statistics principle.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 se
6、lf-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 a
7、nd 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 O
8、bjectives)中国药监局新版统计指南的解读中国 MRCT 指导原则以及 ICH E17数据管理指南/法规的解读新 CDISC 标准与趋势安全性数据的数据管理和统计分析ICH E6(GCP)的修改ICH 风险效益指南、风险效益的定量评估生物等效性试验中的统计方法科学编程最新进展定量科学中药物研发领域职业发展China Statistics GuidanceChina MRCT guidance and ICH E17http:/China Data management guidance/ regulation interpretationICH Risk-benefit guidance
9、 and quantitative evaluation on risk-benefitSafety data management and statistical analysisICH E6 updateStatistical methods in BiosimilarUpdated Progress in Scientific ProgrammingElevation of the Quantitative Profession in Drug Development学习目标 (Learning Objectives)更好的理解新的法规和指导原则及其对定量科学在药物研发中应用的影响探讨监
10、管的环境下从不同角度、多方位、跨学科的对医药产品进行评估探讨在医药研发中指导原则、行业标准和坚持客观标准的重要性A better understanding of the new regulatory guidance and its impact on the implementation of quantitative science in drug developmentDiscuss different ways to evaluate pharmaceutical products from multiple angles in in the regulatory environme
11、ntDiscuss the importance of guidance, standards, and scientific validity in medical product development目标听众 (Target Audience)统计学家临床医生数据管理专家监管科学家学术界中的定量科学专家http:/监管机构中的定量科学专家科学编程专家StatisticiansCliniciansData Management ProfessionalsRegulatory ScientistsQuantitative and Clinical Scientists in Academia
12、Quantitative and Clinical Scientists in Regulatory AgenciesScientific Programming Professionals组委会主席(Program Co-Chairs)陈峰 博士，教授南京医科大学公共卫生学院院长中国卫生统计学会统计理论与方法专业委员会主任委员中国临床试验生物统计学组(CCTS)组长王武保 博士美国默克研究实验室生物统计和科学决策部执行总监Feng CHEN, PhD, ProfessorDean, School of Public Health, Nanjing Medical UniversityChair of China Association of Biostatistics (CABS)Chair of China Clinical Trial Statistics (CCTS) Working GroupWilliam WANG, PhDExecutive DirectorClinical Safety Risk Management Statisticshttp:/Biostatistics and Research Decision Sciences (BARDS)Merck Research Laboratories信息来源：http:/
