2012统计研讨会ICH药物警戒培训课程——法规和实践

学术交流与职业发展的好机会! 请勿错失。

合办单位：ICH

培训重点：

上市前的临床安全性数据管理

上市前和上市后个例安全报告递交的要素

上市药品定期安全性更新报告

上市后安全性数据管理：快速报告的定义和标准

药物警戒计划管理

研发周期安全更新报告

中国与国际市场的案例分析和讨论

培训日程及报名

2012年统计培训研讨会

理解药物临床研究中的统计学思维: 控制临床试验总体假阳性率，确保结果的准确性

2012年10月26-27日

研讨重点：

临床试验假阳性率的总体控制

统计概念及多重比较和多重终点的分析方法

多重终点的问题

期中分析

分组序贯设计和统计分析方法方法

样本量的重估

临床试验实际案例

培训日程及报名

Don’t Miss the Excellent Professional Development Opportunities!

ICH Pharmacovigilance Training - Regulations and Practices

22-24 October, 2012

Co-Sponsor by ICH

Key Topics：

ICH E2A Pre-marketing safety

ICH E2B (both pre-and post –authorization); Data elements for electronic

submission

ICH E2C Periodic safety update report

ICH E2D Definitions & standards for expedited reporting (post –approval)

ICH E2E Pharmacovigilance planning

ICH E2F Development safety update report

Case studies - pharmacovigilance in China and global markets

View Program & Register

2012 Statistical Workshop

Understanding the Statistical Thinking in Clinical Research for Drug Development: Control Overall False Positive Rate in Clinical Trials to Ensure the Validity of Trial Results

26-27 October, 2012

Key Topics:

Control of overall false positive rate

Concept and methodology for multiple comparisons

Issues of multiple endpoints

Interim analysis

Group Sequential Design (GSD) and statistical analysis

Sample size re-estimation

Real life clinical trial examples

View Program & Register

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DIA China

7/F Room 766, Metropolis Tower, No.2 Haidian East Third Street,

Zhongguancun Xi Zone, Haidian District,

Beijing, 100080, China

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Fax. +86.10.6260.2201

email: dia@diachina.org

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