Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan

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 EST)

• 10:00 am EST 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)

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