Module 5: Standards in Clinical Research and Development


Ethics in research and Ethics Committee

30 October, 2006 Monday

0900-1000 Ethics Codes and Guidelines
       
Dr. Vichai Chokevivat, Director, Department of Alternative Medicine, MOH, Thailand

1000-1100 Principles of Research Ethics
       
Prof.Dr. Cristina Torres, FERCAP, Thailand

1100-1130 Tea break

1130-1230 Case study

1230-1400 Lunch

1400-1500 Research methodology and ethical issues (1) Traditional medicine
       
Dr. Vichai Chokevivat, Director, Department of Alternative Medicine, MOH, Thailand

1500-1600 Research methodology and ethical issues (2) Genetic study
       
Prof. Dr. Kenji Hirayama, Nagasaki University, Japan

1600-1630 Tea break

1630-1730 Case study


31 October, 2006 Tuesday

0900-1030 Human Subject Protection and Ethics Committees
       Prof. Dr. Cristina Torres, FERCAP, Thailand

1030-1100 Tea break

1100-1230 Human Subject Protection and Ethics Committees Cont.
       Prof.Dr. Cristina Torres, FERCAP, Thailand

1230-1400 Lunch

1400-1500 Data and Safety Monitoring Board (DSMB)
       Dr. Allan Johansen, Roche Products Pty limited, Australia

1500-1630 Case study

1630-1730 Monitoring and Auditing Ethics Committee
       
Prof. Dr. Cristina Torres, FERCAP, Thailand


1 November, 2006 Wednesday

Quality Standards

0900 - 0930 Concept of Good Clinical Practice
       
Dr. Johansen Allan, Roche Products Pty limited, Australia

0930 -1130 Responsibilities
       Sponsor (Dr. Allan Johansen)
       Investigators (Prof. Kenji Hirayama)
       IRB (Prof. Cristina Torres)
       Monitors (Prof. Juntra Karbwang)
       DSMB (Dr. Allan Johansen)

1130 - 1200 Audit and Inspection
       
Dr. Johansen Allan, Roche Products Pty limited, Australia

1200-1300 Lunch

1400-1530 New Asymmetric Catalysis, Leading to the synthesis of Tamiflu.
        
Prof.Dr. Masakatsu Shibasaki, The University of Tokyo, Japan


2 November, 2006 Thursday

In the morning: Field Trip to Kaketsuken, Kumamoto by Bus:

1300-1700 Good Manufacturing Practice (GMP)
       Good Laboratory Practice (GLP)
       
Dr.Tetsuro Satoh, Kaketsuken, Kumamoto, Japan

       Visit GMP lab and GLP lab and Plant for vaccine production


3 November, 2006 Friday Holiday


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