Japanese Pharmacology & Therapeutics (JPT)
Vol. 43 Suppl. 2 2015
■ SYMPOSIUM
【Preparations to Recieve Inspections of Foreign Organizations and the Role of CRC in Japan】
The Practice and Measures for FDA Inspection: From the Standpoint of Medical Institution
M. Kubo
Jpn Pharmacol Ther 2015 43(s2) s162-6
The Practice and Measures for EMA Inspection
M.Yoshioka
Jpn Pharmacol Ther 2015 43(s2) s167-73
Present Situation of Inspections Concerning International Clinical Trials
N. Kobayashi
Jpn Pharmacol Ther 2015 43(s2) s174-5
【Risk Based Approach : Monitoring and Audit Quality Management in Clinical Research】
Improving Quality of Clinical Trials and Research in Japan
H. Watanabe
Jpn Pharmacol Ther 2014 42(s2) s176-9
The Importance of the Central Monitoring in the Clinical Research Group for Physician-led Trials
R.Kitagawa
Jpn Pharmacol Ther 2015 43(s2) s180-4
Risk Based Approach for Quality Management (QM) in Clinical Trial
K. Iwasaki
Jpn Pharmacol Ther 2015 43(s2) s185-91
Monitoring and Audit at Academic Research Organization in Japan
H. Oi
Jpn Pharmacol Ther 2015 43(s2) s192-7
Problem and Solution on Conducting the Clinical Trials
K. Yoshida
Jpn Pharmacol Ther 2015 43(s2) s198-202
■ORIGINAL ARTICLE
Adverse Event Reporting in Clinical Investigations
－Comparing Roles and Responsibilities for Multi-center Clinical Trials in the ICH-GCP and the New Japanese Guidance－
H. Shinano, et al.
Jpn Pharmacol Ther 2015 43(s2) s227-38