Education and training in April 2015

2015/04/11  13:00-17:00  Biostatistics lesson for Clinical Trials and Research- Part 1

13:10-14:00  Statistics and data management in clinical trial

14:00-14:50  Statistical Analyses in GCP specification

15:10-16:00  Statistical Consideration in the Design of Clinical Trials

16:00-16:50  Data analysis for clinical trial progress report

2015/04/17  12:00-14:00  Clinical trial and human research protection -Part 1

12:00-12:20  Clinical trial ethics and HRPP

12:20-12:40  The application and management for the clinical trial

12:40-13:00  The clinical trial drugs and medical device management

13:00-13:20  Introduction JIRB review information system application and conflict of interesting

13:20-13:40  Audit, DSMP and DSMB

13:40-14:00  Protection of subject and subject rights

2015/04/18  13:00-17:00  Auditor training of clinical trial- Part 3

13:10-14:00  The clinical trial research requirement for study auditor communication and challenge

14:00-14:50  Auditor at conflict of interesting, risk assessment and human protection for Research

15:10-16:00  Introduction of FDA and Japan international GCP inspection

16:00-16:50  Introduction of EMA and Malaysia international GCP inspection

2015/04/21  12:00-14:00  Clinical trial and human research protection- Part 2

12:00-12:20  Clinical trial ethics and HRPP

12:20-12:40  The application and management for the clinical trial

12:40-13:00  The clinical trial drugs and medical device management

13:00-13:20  Introduction JIRB review information system application and conflict of interesting

13:20-13:40  Audit, DSMP and DSMB

13:40-14:00  Protection of subject and subject rights

2015/04/24  12:00-14:00  Clinical trial and human research protection- Part 3

12:00-12:20  Clinical trial ethics and HRPP

12:20-12:40  The application and management for the clinical trial

12:40-13:00  The clinical trial drugs and medical device management

13:00-13:20  Introduction JIRB review information system application and conflict of interesting

13:20-13:40  Audit, DSMP and DSMB

13:40-14:00  Protection of subject and subject rights

2015/04/25  13:00-17:00  Biostatistics lesson for Clinical Trials and Research- Part 2

13:10-14:00  Statistical Analyses in ICH E9

14:00-14:50  Controversial Statistical Issues in Clinical Trials

15:10-16:00  IRB members protocol review points at statistical consideration

16:00-16:50  Tips to develop on biostatistics concern of a clinical study protocol and suggestion

2015/04/27  12:00-14:00  Clinical trial and human research protection- Part 4

12:00-12:20  Clinical trial ethics and HRPP

12:20-12:40  The application and management for the clinical trial

12:40-13:00  The clinical trial drugs and medical device management

13:00-13:20  Introduction JIRB review information system application and conflict of interesting

13:20-13:40  Audit, DSMP and DSMB

13:40-14:00  Protection of subject and subject rights