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      Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment in Pune

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      July 13, 2012

      Friday   7:00 AM - 1:00 PM

      Online
      Pune, Mahārāshtra

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      EVENT DETAILS
      Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment

      This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

      Why Should You Attend:

      This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes, will also be discussed.

      Agenda: (All time in EDT)

      - 10:00 am EDT to 12:00 noon (Session I)
      - 12:00 noon to 1:00 pm (Lunch)
      - 1:00 pm to 3:00 pm (Session II)
      - 3:00 to 3:15 pm (Break)
      - 3:15 to 3:45 pm (Conclusions and Final Comments)
      - 3:45 - 4:00 pm (Q&A Session)

      Cost: Payment required - 749.00

      Categories: Conferences & Tradeshows | Education

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
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