8月17日

(星期五)

9:00-12:00

14:00-17:00

药品质量保证体系的动态维护

1.新版GMP的主要变化及对质量保证体系的要求

2.当代药业的质量管理体系及质量源于设计（QbD）

3.质量授权人 4.关键人员

5. 变更管理和稳定性研究 6.自检与审计

7.产品质量回顾分析 8.验证体系和质量控制战略

主讲人：孙悦平 WHO外聘顾问、GMP和国际药品注册高级咨询 原比利时杨森、德国汉姆等中国区经理

8月18日

(星期六)

9:00-12:00

14:00-17:00

一、 什么是质量体系，如何建立与实施

1．制药质量体系最佳图解，

2．制定出好的SOP的欧美标准（写你所做）

3．如何规范记录（记你所做）：永久性、一致性、可读性、完全性、

准确性、直接性、及时性、真实性

4. 如何持续提高（改你所错）

—CAPA的最佳实践

—生产偏差、偏差与广义偏差的关系与扩展

二、偏差调查与OOS调查

1．偏差调查的注意问题 ：偏差调查的科学性，偏差的根本原因，偏差的扩展调查，偏差调查与质量成本；

2．全球制药偏差典型案例分析

3．OOS调查注意问题

4．全球制药OOS典型案例分析

三、企业如何实施质量风险管理

TGA的质量风险审计与期望要求、PIC/S质量风险管理执行与检查评估、

我国GMP对质量风险管理的要求与检查等

主讲人：李永康 资深专家 新版GMP指南编写人员，曾在欧美药企任职高管，熟悉美国药典，欧洲药典的使用，负责起草过二个品种的《中国药典》二部和《中国药典》二部《药典注释》，主持或参予过FDA/SFDA的GMP（新版）认证检查工作，国家药监局培训讲师

8月19日

(星期日)

9:00-12:00

14:00-17:00

建立并实施文件化的生产质量管理保证体系

1.文件管理的法规要求 2．文件的要素

3．GMP文件的编制 4．文件的记录与管理

5．文件的修改与维护 6．GMP现场检查文件等

主讲人：国内GMP专家，国家食品药品监督管理局认证中心教师，曾多次为GMP检查员、各省局和制药企业进行培训，曾多次进行企业指导，有丰富的指导企业通过认证的经验

Michael B. Bolger

Chief Scientist

Simulations Plus Inc.

Dr. Bolger is Chief Scientist at Simulations Plus, he oversees a team of scientist / programmers at Simulations Plus, Inc. (Lancaster, CA) in the development of software programs (ADMET Predictor/Modeler, MedChem Studio/Designer, GastroPlus, DDDPlus, and MembranePlus) for estimation of biopharmaceutical properties, simulations of absorption and bioavailability, automated generation QSP/AR model building, in vitro dissolution, and cell culture permeability simulation.

As a faculty member at USC School of Pharmacy, his research was supported by several NIH basic science research grants and he published over 50 peer-reviewed publications. From 1989-1991 he served as a FDA National Science Advisor. He has served as a reviewer for numerous scientific publications. He is currently Adjunct Associate Professor of Pharmaceutical Sciences at USC.

Haiying Zhou, Ph.D.

Senior Scientist II

Simulations Plus Inc.

She received her M.S. degree in automation from East China University of Science and Technology (ECUST) in 2002 and her Ph.D in Biomedical Engineering from Case Western Reserve University (CWRU) in 2009. Her research interests in CWRU include multi-scale mathematical modeling of gas transport and cellular metabolism with emphasis on the metabolic regulation during different conditions, e.g. hypoxia and exercise.

John DiBella

Vice President of Marketing Simulations Plus Inc.

Michael B. Bolger

Chief Scientist

Simulations Plus Inc.

Dr. Bolger is Chief Scientist at Simulations Plus, he oversees a team of scientist / programmers at Simulations Plus, Inc. (Lancaster, CA) in the development of software programs (ADMET Predictor/Modeler, MedChem Studio/Designer, GastroPlus, DDDPlus, and MembranePlus) for estimation of biopharmaceutical properties, simulations of absorption and bioavailability, automated generation QSP/AR model building, in vitro dissolution, and cell culture permeability simulation.

As a faculty member at USC School of Pharmacy, his research was supported by several NIH basic science research grants and he published over 50 peer-reviewed publications. From 1989-1991 he served as a FDA National Science Advisor. He has served as a reviewer for numerous scientific publications. He is currently Adjunct Associate Professor of Pharmaceutical Sciences at USC.

Haiying Zhou, Ph.D.

Senior Scientist II

Simulations Plus Inc.

She received her M.S. degree in automation from East China University of Science and Technology (ECUST) in 2002 and her Ph.D in Biomedical Engineering from Case Western Reserve University (CWRU) in 2009. Her research interests in CWRU include multi-scale mathematical modeling of gas transport and cellular metabolism with emphasis on the metabolic regulation during different conditions, e.g. hypoxia and exercise.

John DiBella

Vice President of Marketing Simulations Plus Inc.

12月9日全天

大会报到

12月10日上午

大会开幕

大会主席：凌锋　黄燕

专家讲座

12:00—13:30

午餐休息

12月10日下午

平行分会：

分会1：血管神经内科专场

主持人：赵性泉　李小刚

分会2：血管神经外科专场

主持人：肖绍文　赵振伟

分会3：血管神经护理专场

主持人：张广清陆新容

分会4：血管神经修复与再生

主持人：杨万章 徐运

18:30—20:30

欢迎晚宴

12月11日上午

平行分会：

分会1：血管神经内科专场

主持人：黄 燕　梁伟雄

分会2：血管神经外科专场

主持人：李铁林　陈左权

分会3：血管神经护理专场

主持人：黄惠根刘雪琴