时间 |
专家 |
报告题目 |
主持人Chairman |
8:30-9:00 |
Leader |
开幕式:致欢迎辞(Opening Ceremony) |
杨化新 Huaxin Yang |
Elizabeth Ray Delong |
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9:00-9:40 |
Harry Yang |
用统计取得监管优势 Getting Regulatory Upper Hand Using Statistics |
杨化新 Huaxin Yang & Elizabeth Ray Delong |
9:45-10:25 |
Elizabeth Ray Delong |
大数据和FDA哨兵计划---FDA批准产品的安全性监测 Big Data and the FDA's Sentinel Program—Monitoring the Safety of FDA-Approved Medical Products |
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10:30-10:40 |
茶歇(Tea Break) |
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10:40-11:15 |
Xiao-fei Wang |
药品监管中的大数据应用 Application of big data in Drug regulatory administration |
杨化新 Huaxin Yang & Elizabeth Ray Delong |
11:20-12:00 |
William Ed Hammond |
标准:交互操作性的关键 Standards: The Key to Interoperability |
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12:00-13:30 |
午餐与休息(Lunch) |
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13:30-14:10 |
Shein-Chung Chow |
生物相似药评估及其最新研究进展 Analytical Similarity Assessment – Issues and Recent Development |
杨文良 周贤忠 Wenliang Yang &Shein-Chung Chow |
14:15-14:55 |
项荣武 Rong-wu Xiang |
药品一致性评价中的统计技术应用及最新研究进展 Statistical techniques for evaluation of generics and their latest progress |
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15:00-15:10 |
茶歇(Tea Break) |
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15:10-15:50 |
司端运 Duan-yun Si |
仿制药生物等效性评价的统计学要求与研究方案设计Bioequivalence Assessment for Generics: Statistic Requirement and Study Design |
杨文良 周贤忠 Wenliang Yang &Shein-Chung Chow |
15:55-16:35 |
Jichun Xie |
协变量分位数关联条件的高维网络错误发现率控制及其在癌症生存实验中基因共表达网络变化的应用 False Discovery Rate Control for High-Dimensional Networks of Quantile Associations Conditioning on Covariates with An Application in Identifying Gene Co-expression Network Change Associated with Cancer Survival. |
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16:40-17:20 |
陈华 Hua Chen |
药品检测实验室检测能力的控制与评估 The control and evaluation for Proficiency of medicine control laboratory |
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Q & As 10min |
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May 19 |
Second day |
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时间 |
专家 |
报告题目 |
主持人Chairman |
8:30-9:10 |
冯国双 Guo-shuang Feng |
药品质量检测中等效性检验及等效区间的确定 Application of Equivalence Test and the ways to setting up Equivalence interval in drug quality analysis |
胡德福
De-fu Hu
& |
9:15-9:50 |
许明哲 Ming-Zhe Xu |
药品检验方法验证和确认中统计技术要求及最新进展latest progress in the requirements of method validation and verification |
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9:55-10:05 |
茶歇(Tea Break) |
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10:05-10:45 |
Harry Yang |
生物活性测定方法的validation指标及评价方法 validation characteristics and evaluation methods for bioassays |
胡德福
De-fu Hu
& |
10:50-11:20 |
耿颖 Ying Geng |
药品检验中理化方法验证指标的评估研究 validation characteristics and evaluation methods for physical-chemical analysis |
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11:25-12:00 |
常艳 Yan Chang |
抗生素微生物检定法的替代研究 statistical demonstration of alternative method in microbiological tests |
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12:00-13:30 |
午餐与休息(Lunch) |
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13:30-14:10 |
陈家松 Jia-song Chen |
现代化的数据分析技术助力制药行业走出仿制药领域困境 Advance data analytic technology help pharmaceutical industry to overcome the challenge of generic drugs field |
谭德讲 王晓飞 De-jiang Tan &Xiaofei Wang |
14:15-14:50 |
徐为人 Wei-ren Xu |
药品质量评价中的计算机模拟技术应用 Application of in silico technics in drug quality assessment |
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14:55-15:05 |
茶歇(Tea Break) |
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15:05-15:40 |
张宏亮 Hong-liang Zhang |
药品生产工艺和质量分析中的风险评估应用 Application of risk assessment in medical product process and quality analysis |
谭德讲 王晓飞 De-jiang Tan &Xiaofei Wang |
15:45-16:20 |
周暐 William Zhou |
现代化数据分析技术助力“质量源于设计”理念的实现和落地 Realization of Quality-by-Desigh (QbD) Concept by Modern Data Analytical Technology |
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16:25-17:00 |
谭德讲 De-jiang Tan |
产品质量标准中限度的确立和评价原则 Principles for setting up and evaluation of the limits and ranges in product specification |
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17:00-17:15 |
Q & As 10min |
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17:20-17.30 |
大会总结The conference summary |
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