Module5: Good Clinical Practice

August 24, Thursday (Day 4)

Discribe the concepts of GCP, Recognise the principles of Ethics in research and the functions of Ethics Committee

13:00-13:30 Concept of Good Clinical Practice
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
13:30-14:30 Principles of Research Ethics and Ethics codes and Guidance
Professor Dr. Juntra Karbwang, Nagasaki University, Japan
14:30-14:45 Break
14:45-15:45 Responsibilities: Sponsor, Monitors, audit, DSMB
Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand
15:45-16:00 Clinical Data Management
Professor Dr. Kesara Na-Bangchang, Thammasat University, Thailand
16:00-16:30 Exam 3 Module 5
Profeesor Dr. Hirayama or Professor Dr. Kesara

August 25, Thursday (Day 5)

Field Trip to Hisamitsu Pharmaceutical Co.,Inc

10:00-17:00 Mr.Hideyuki Nakano,Hisamitsu Pharmaceutical Co.,Inc


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