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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V3-S5] Trend and Challenges of GCP Inspection by Overseas Regulatory Authorities

Session Chair(s)

Tatsuya  Murakami

Tatsuya Murakami

Senior Director, Head of Clinical Operations

Pfizer R&D Japan G.K., Japan

In recent years, Japan has participated in MRCTs from early phases, and the simultaneous global application and approval of drugs is no longer a dream. However, MRCTs and simultaneous global application have increased the opportunities of GCP Inspections by overseas regulatory authorities, such as the FDA or EMA, to ensure reliability mutual, global use of the application data. It is also not uncommon that we experience confusion in the procedure, survey content, thresholds, and data handling of GCP violations. This session will introduce cases of GCP inspections at a clinical trial facility and pharmaceutical companies by the FDA and the EMA, and exchange suggestions for future GCP inspection challenges. In addition, the panel discussion will feature PMDA perspectives on these challenges.

Speaker(s)

Takako  Kuwaki

Experience of FDA Inspections - Clinical Investigator

Takako Kuwaki

National Cancer Center, Japan

Research Audit Section

Hiroshi  Furukawa

Experience of EMA GCP Inspection

Hiroshi Furukawa

Novartis Pharma K.K., Japan

Quality System Group, CPO QA Japan Department

Takashi  Nakagawa

FDA vs. EMA vs. PMDA: Similarities and Differences on Inspection

Takashi Nakagawa

Nippon Boehringer Ingelheim Co., Ltd., Japan

Compliance Group Manager, Compliance Group, Quality Medicine, Medical Division

Makoto  Hirose, MSc

Makoto Hirose, MSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Office Director, Office of Non-clinical and Clinical Compliance

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