Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompliancePanel

• Japan's Regulatory Structure for the Life Science Product Industries
  
  • Demographic Overview
  • Regulatory Framework:  Key Agencies Involved / Reporting Structure
  • Recent Changes to MHLW / PMDA to Speed Review
    • MHLW (Ministry of Health, Labour and Welfare)
    • PMDA  (Pharmaceutical and Medical Device Agency)
    • PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
  • Patents and Trademark Considerations
• Beginning Your Company Involvement in Japan
  
  • Local Office and Personnel Requirement Options
  • Language Requirements
  • Possible License Types
• Objectives of the Rules Governing Medicinal Procedures
  
  • Market Authorization Holder Overview
• Life Science Regulations and the Regulatory Processes in Japan
  
  • Pre-Clinical
  • Conducting Clinical Trials
  • New Product Registrations & Filings
  • Post-Marketing Requirements
  • Pricing & Reimbursement
• Japan's Use of ICH Standards / Principles
  
  • GCP
  • GMP
  • CTD / e-CTD Submissions
• Starting-Up and Conducting Clinical Trials
  • Clinical Trial Start-Up process
    • Japan's Effort to Reduce "The Drug Lag"
    • Japan's Desire to Eliminate Bridging Studies and Participate in Ph. III Global Trials

• Marketing Authorization Processes – Filings & Registrations
  
  • Pharmaceutical Affairs Law (PAL) & Drug Registration
  • Medical Devices
  • Biologic Considerations
  • Developing Combination Products; Classification and Licensing Review
  • Drug Master File (DMF) Use in Japan
  • Labeling Requirements
  • Package Insert Requirements
• Variations: Changes to Marketed Products
  
  • Types of Variations
  • Variation Filings and Typical Review Times
• License Renewals
  
  • Japan's Process; What has recently changed
  • License Terms
  • Maintenance Responsibilities
• Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
  
  • Comparison of Processes
  • Agency Interactions
  • Accepted Practices
• How and When to Influence the Regulatory Process
  
  • Japanese Way of Thinking / Coming to Agreement
  • Important Cultural Issues for Consideration
  • The Do's and Don'ts of Regulatory Involvement in Japan
• How to Use Regulations / Regulatory Contacts to Your Advantage
  • Agency Interactions
  • Business Impact Within and Outside of Japan
  • Professionalism in Regulatory Affairs

Who Will Benefit: This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one's Business Strategy.

• Regulatory personnel whose responsibilities require knowledge of Japan's regulatory environment.
• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.