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Fast Facts


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)

Areas Covered in the Seminar:-

Part I: Japan Regulatory Compliance

  • Overview of Japan's Healthcare System.
  • Japan's Regulatory Agency's Structure and Responsibilities.
  • Japanese Drug Development Process.
  • Agency Review Process for Decision-Making.
  • Country Establishment Licensing & Procedures – Requirements for Conducting Clinical Research.
  • Japan and ICH (International Conference on Harmonization).
  • Requirements for Clinical Trials in Japan.
  • Japan's Desire for Innovative Products.
  • How Japan Wants to be Involved in Clinical Trials.
  • The Changing PMDA.
  • Conducting Meetings with the Agency.
  • Japanese Philosophy in Risk Evaluation.
  • How to Apply for Clinical Trials in Japan; the CTA.
  • Amending the CTA.

Part II: Conducting Clinical Studies in Japan

  • Japan's Clinical Investigational Plan (CIP).
  • Likely Parameters Defining Clinical Trials; What to Anticipate.
  • Clinical Trial Start-Up; GCP and GMP Requirements.
  • Importing the IMP & Supplies into Japan.
  • Product Labeling Requirements.
  • Finding & Hiring CROs in Japan.
  • Conducting Clinical Trials in Japan.
  • Special Product Considerations.
  • Clinical Trial Pharmacovigilance Reporting.
  • CT Close-out and Reporting Requirements.
  • Cultural Aspects – Working in Japan.
  • Effectively Working with the Regulators; Do's and Don'ts, Practical Experiences Shared.

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Event Profile

Sponsors: ComplianceOnline
Speakers: Robert J. Russell
Attendees: Clinical Trial Project Managers, QA / QC Personnel, Global Supply Chain personnel, Manufacturing personnel

Contact Details

Contact person: Referral
Event website:
Phone: +1-650-620-3915
Fax: +1-650-963-2556

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