October 26, Wednesday (Day 13)
Objective: To describe the concepts of GCP, Recognise the principles of Ethics in research and the functions of Ethics Committee
9:00-10:00 Good clinical practice and quality management in clinical research
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerland
10:00-10:15 Tea break
10:15-12:15 Responsibilities: sponsor, investigators, IRB, monitors, DSMB
Dr. Allan Johansen, Roche Products Pty limited, Australia
12:15-13:15 Lunch
13:15-14:15 Ethics codes and guidelines
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerland
14:15-14:30 Tea break
14:30-15:30 Principles of research ethics
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerland
15:30-16:30 Protection of intellectual property rights in developing countries
Professor Hiroko Yamane, Faculty of Law, Teikyo University
16:30-17:30 Case studies
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerland Professor
October 27, Thursday (Day 14)
9:00-10:00 Case study presentation (Group work)
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerlan
10:00-10:15 Tea break
10:15-11:15 Human subject protection and ethics committees
Professor Dr. Juntra Karbwang-Laothavorn, TDR/WHO, Switzerland
11:15-12:15 Monitoring and auditing ethics committee
Dr. Allan Johansen, Roche Products Pty limited, Australia
12:15-13:15 Lunch
13:15-14:15 Data and Safety Monitoring Board: DSMB
Dr. Allan Johansen, Roche Products Pty limited, Australia
14:15-14:30 Tea break
14:30-15:30 Audit and inspection
Dr. Allan Johansen, Roche Products Pty limited, Australia
15:30〜 Review and exam (Module 5)
Professor Dr. Kenji Hirayama and Professor Dr. Juntra Karbwang-Laothavorn