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. 

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.

Who Will Benefit:

This course will be beneficial to:

• Clinical / Pharma & Device personnel
• Clinical Trial Project Managers
• Monitors / CRAs
• QA / QC Personnel
• Pharmacovigilance reporting personnel
• Regulatory personnel whose responsibilities require knowledge of Japan's Regulatory and Clinical Trial environment
• Global Supply Chain personnel
• Manufacturing personnel
• Global Business Development personnel
• All personnel who need to understand the procedures and impact of placing Medical Devices on the Market across the EU