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Investigator Initiated Trial (IIT) A View from Industries

Investigator Initiated Trial (IIT) A View from Industries. Dr.M.Iwasaki (Aventis Pharma). New Movement. Manual for IIT Prof. Ueda’s 2 nd Task Force on GCP Basis for coming MHLW Notification Notification is planned in March ’04 Educational seminar (ex, JSCO) Preparation of a IIT at NCC

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Investigator Initiated Trial (IIT) A View from Industries

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  1. Investigator Initiated Trial (IIT)A View from Industries Dr.M.Iwasaki (Aventis Pharma) The 4th Kitasato-Harvard Symposium

  2. New Movement • Manual for IIT • Prof. Ueda’s 2nd Task Force on GCP • Basis for coming MHLW Notification • Notification is planned in March ’04 • Educational seminar (ex, JSCO) • Preparation of a IIT at NCC • Several proposals to the industries The 4th Kitasato-Harvard Symposium

  3. A Message from Us • Fundamental support for IIT • We should take this activity positively • As it gives us opportunity to provide more efficient clinical trial methodology to investigators • As it gives also investigators opportunity to recognize the real world of “Clinical Studies” • Need to clarify issues for improvement • Ready to continue collaboration The 4th Kitasato-Harvard Symposium

  4. Proposals • A face to face meeting with the key player for IIT • Clarify uncertainties / issues • Seek for the way to solve them • Introduction of a process that enables us to check the scientific, ethical and administration matters of IITs • For the better mutual understanding The 4th Kitasato-Harvard Symposium

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