标准化的试验数据能够大幅提高药物研发的效率与成功率，支持科学性的审评并缩短审评时间，数据标准化势在必行。中国NMPA发布的《药物临床试验数据递交指导原则》中指出鼓励申办方参照CDISC标准递交临床试验数据。美国FDA今年5月新发布的《STUDY DATA TECHNICAL CONFORMANCE GUIDE》对药物研发试验数据递交提出了进一步要求。申办者在IND、NDA、ANDA和BLA研究中应以标准化电子格式提交非临床与临床研究数据，在递交前应当对研究数据进行验证和评估，纠正研究数据与要求的标准和业务规则之间的差异或在数据审阅说明（RG）中提供合理解释以及数据的可溯源等，确保研究数据合规、有用，并支持监管审评和分析。
Pinnacle 21 Enterprise是利用高质量数据支持知情决策领域的全球实践者，包括为向监管机构申报递交准备非临床与临床试验数据。我们的客户能够验证试验数据质量、使之符合 CDISC 标准、实现从数据管理团队到生物统计团队再到卫生当局的顺畅的数据管道。美国 FDA自2011年和日本 PMDA自2015年使用Pinnacle 21 Enterprise用于审评申报资料的数据质量、CDISC 合规性与数据适用性，帮助简化审批流程从而患者更早地受益于安全有效的药物。
Certara公司Pinnacle 21资深专家以及特邀行业专家和用户将在上海举办线下研讨会与大家面对面深入交流。希望借此机会与国内同行交流国际上数据标准化及数据递交的新进展和未来趋势，为中国创新药物进军国际市场提供思路和实践经验。
一、会议信息
主办单位：Certara 科盛达 ( 上海 ) 医药咨询有限公司
协办单位：源资信息科技（上海）有限公司
会议时间：2023年8月16日13:00-17:00（星期三）
会议地点：上海苏宁环球万怡酒店（上海市普陀区丹巴路 99 号）
参会人群：药物研发企业及CRO负责人，生物统计人员，统计编程人员，数据管理人员，注册人员，医学人员。
二、会议日程
13:00 | Registrantion
13:30 | Opening Welcome
Marco Ding & Monica Dong, Certara
13:40 | Pinnacle 21 Enterprise introduction & Case studies
Philip Johnston, Certara Director of Product
14:30 | Pinnacle 21 Enterprise Helps to Improve Data Fitness Score for e-Submission: A Case Study
Jianling Ren, Hengrui Director of Statistical Programming
15:10 | Tea Break
15:20 | A case sharing of ISS/ISE E-submission to FDA via P21 Enterprise
Cherry Chen, R&G Pharma Studies Function Leader
16:00 | P21E Data Exchange/SPEC Management introduction & Case studies
Erin Erginer, Certara Director of Product
16:30 | Open Discussion
All
17:00 | Group Photo
All
三、嘉宾介绍
Philip Johnston
Product leader for life sciences software development in the non/clinical trial data sector. Track record of designing and/or implementing solutions for regulatory agencies, nonclinical laboratories, and clinical Sponsors & Contract Research Organizations. Leader of Certara Cloud, and responsible for Pinnacle 21 Enterprise. Passionate about creating a smooth data pipeline from Data Management and Biostatistics teams to health authorities such as the FDA, PMDA and NMPA.
Jianling Ren
Jianling Ren holds a Master degree in Epidemiology and Healthy Statistics from the Second Military Medical University. She is now director of statistical programming in Jiangsu Hengrui Pharmaceuticals Co.,Ltd with 14 years’ programming experience in clinical trials, mainly focused on oncology, diabetes, rheumatoid arthritis and hyperuricemia. She has experience of data submission to NMPA and FDA. Before joining Hengrui, she had worked at Pfizer for more than 7 years.
Cherry Chen
Function leader in R&G Pharma Studies with 16 years of statistical programming experience. Provides statistical programming support for more than 300 projects as individual contributor or team leader since 2016. Lead or assist more than 50 submissions to FDA, NMDA or PMDA, including ISS/ISE strategies from multiple studies. Drive for excellence to provide efficient E-submission strategy and solutions for new drug application.
Erin Erginer
Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations.
四、参会报名
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