Session information

Special Prgram

CVIT Town Hall Meeting 1

レジストリデータを薬事承認に生かすためには？～事例から学ぼう～

Fri. Sep 20, 2019 8:00 AM - 8:40 AM Room 8 (Bldg1,3F)

Chair:Tetsuya Amano(Aichi Medical University), Yukio Ozaki(Fujita Health University), Shin Iwamoto(PMDA)

Japanese

+Add all to schedule

[SP1-1] The current situation of J-PCI registry from CVIT

^○Shun Kohsaka (Keio University School of Medicine)

[SP1-2] The current situation ofJ-EVT registry from CVIT

^○Osamu Iida (Kansai Rosai Hospital Cardiovascular Center)

[SP1-3] Points to consider reliability of registiry data for using regulatory decision making

^○Manabu Hayashi (PMDA)

[SP1-4] Prospective and points to consider the ultilization of real-world evidence for regulatory decision-making - Reviewer's view-

^○Sara Takahashi (PMDA)

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