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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

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The Practice and Measures for EMA Inspection

M.Yoshioka

Jpn Pharmacol Ther 2015　43(s2) s167-73

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Present Situation of Inspections Concerning International Clinical Trials

N. Kobayashi

Jpn Pharmacol Ther 2015　43(s2) s174-5

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【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

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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

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Risk Based Approach for Quality Management (QM) in Clinical Trial

K. Iwasaki

Jpn Pharmacol Ther 2015　43(s2) s185-91

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Monitoring and Audit at Academic Research Organization in Japan

H. Oi

Jpn Pharmacol Ther 2015　43(s2) s192-7

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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