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

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)

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.