2012统计研讨会ICH药物警戒培训课程——法规和实践

作者:   2012-08-13
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  • 会议时间: 2012-10-22至 2012-10-27
  • 会议地点: 北京
  • 电话:86.10.6260 2240
  • 传真:86. 10.62602201
  • 联系人:赵英
  • Email: dia@diachina.org
  • 联系地址:中国北京海淀区中关村西区海淀东三街2号,欧美汇大厦七层766室,邮编100080
  • 会议网址:www.diachina.org

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

DIA中国办公室 (DIA CHINA OFFICE)

中国北京海淀区中关村西区海淀东三街2号,欧美汇大厦七层766室,邮编100080

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

Xi Zone, Haidian District, Beijing, 100080, China

Tel: +86.10.6260.2240         Fax: +86.10.6260.2201

Email: dia@diachina.org        Web: www.diachina.org

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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

Tel. +86.10.6260.2240

Fax. +86.10.6260.2201

email: dia@diachina.org

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