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[V3-S5] Trend and Challenges of GCP Inspection by Overseas Regulatory Authorities
Session Chair(s)
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
Research Audit Section, National Cancer Center, Japan
Experience of FDA Inspections - Clinical Investigator
Hiroshi Furukawa
Quality System Group, CPO QA Japan Department, Novartis Pharma K.K., Japan
Experience of EMA GCP Inspection
Takashi Nakagawa
Compliance Group Manager, Compliance Group, Quality Medicine, Medical Division, Nippon Boehringer Ingelheim Co., Ltd., Japan
FDA vs. EMA vs. PMDA: Similarities and Differences on Inspection
Makoto Hirose, MSC
Office Director, Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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