Module 5: Good Clinical Practice
Ethics
in research and Ethics Committee
26
October, 2007 Friday
0900-1000 Ethics Codes and Guidelines
Dr.Benjamin
Kuo, FERCAP,
1000-1100 Principles
of Research Ethics
Dr. Benjamin Kuo, FERCAP,
1100-1115 Tea Break
1115-1230 Principles of Research Ethics - case
studies
1230-1400 Lunch
1400-1500 Research
methodology and ethical issues (1) Traditional medicine
1500-1600 Research
methodology and ethical issues (2) Genetic study
Prof. Dr. Kenji Hirayama,
1600-1630 Tea break
1630-1730 Case studies
Prof. Dr. Kenji Hirayama,
27
October, 2007 Saturday
0900-1030 Human Subject Protection and Ethics
Committees
Dr.Benjamin Kuo, FERCAP,
1030-1100 Tea break
1100-1230 Human Subject Protection and Ethics
Committees Cont.
Dr.Benjamin Kuo, FERCAP,
1230-1330 Lunch
1330-1430 Monitoring and Auditing Ethics
Committee
Dr. Allan Johansen,
Roche Products Pty limited, Australia
1430-1530 Data
and Safety Monitoring Board (DSMB)
Dr. Allan Johansen,
Roche Products Pty limited,
1530-1545 Tea Break
1545-1630 Case studies
Dr.
Allan Johansen,
Roche Products Pty limited, Australia
29 October,
2007 Monday
Quality
Standards
0900-0930 Concept of Good Clinical Practice
Prof.
Dr. Juntra Karbwang
0930-1230 Responsibilities
Sponsor (Dr.
Allan Johansen)
Investigators
(Prof. Dr. Kenji Hirayama)
IRB (Prof. Dr. Juntra Karbwang)
Monitors
(Prof. Dr. Juntra Karbwang)
DSMB
(Dr. Allan Johansen)
1230-1330 Lunch
1330-1530 Audit and Inspection
Dr.
Allan Johansen,
Roche Products Pty limited, Australia
30 October, 2007 Tuesday
In the morning: Field Trip to Hisamitsu
Pharmaceutical by Bus:
1300-1700 Good
Manufacturing Practice (GMP)
Good
Laboratory Practice (GLP)
Topics
of Product development
Pharmacy
Museum
Visit
GMP lab and GLP lab and Plant for Drug production