时间
Time

专家
Speaker

报告题目
Title of the speeches

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

9:00-9:40

Harry Yang

用统计取得监管优势

Getting Regulatory Upper Hand Using Statistics

杨化新
伊丽莎白·德隆

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

10:30-10:40

茶歇(Tea Break)

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
伊丽莎白·德隆

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

12:00-13:30

午餐与休息(Lunch)

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

15:00-15:10

茶歇(Tea Break)

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.

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

Q & As  10min

May 19

Second day

时间
Time

专家
Speaker

报告题目
Title of the speeches

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
杨鹤飞

De-fu Hu &
 Harry Yang

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

9:55-10:05

茶歇(Tea Break)

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
杨鹤飞

De-fu Hu &
Harry Yang

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

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

12:00-13:30

午餐与休息(Lunch)

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

14:55-15:05

茶歇(Tea Break)

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

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

17:00-17:15

Q & As  10min

17:20-17.30

大会总结The conference summary