Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment 2012

Key Topics

• Conducting Clinical Studies in Japan
  
  • Likely Parameters Defining Clinical Trials; What to Anticipate
  • Japan’s Clinical Investigational Plan (CIP)
  • Importing the IMP & Supplies into Japan
  • Clinical Trial Start-Up; GCP and GMP Requirements
  • Finding & Hiring CROs in Japan
  • Product Labeling Requirements
  • Special Product Considerations
  • Conducting Clinical Trials in Japan
  • CT Close-out and Reporting Requirements
  • Clinical Trial Pharmacovigilance Reporting
  • Effectively Working with the Regulators; Do’s and Don’ts, Practical Experiences Shared
  • Cultural Aspects – Working in Japan
• Japan Regulatory Compliance
  
  • Japan’s Regulatory Agency’s Structure and Responsibilities
  • Overview of Japan’s Healthcare System
  • Agency Review Process for Decision-Making
  • Japanese Drug Development Process
  • Japan and ICH (International Conference on Harmonization)
  • Country Establishment Licensing & Procedures – Requirements for Conducting Clinical Research
  • Japan’s Desire for Innovative Products
  • Requirements for Clinical Trials in Japan
  • The Changing PMDA
  • How Japan Wants to be Involved in Clinical Trials
  • Japanese Philosophy in Risk Evaluation
  • Conducting Meetings with the Agency
  • Amending the CTA
  • How to Apply for Clinical Trials in Japan
• Conducting Clinical Studies in South Korea
  
  • Clinical Trial Start-Up; ICH GCP and GMP Requirements
  • Likely Parameters Defining Clinical Trials; What to Anticipate
  • Product Labeling Requirements
  • Importing the IMP & Supplies into South Korea
  • Conducting Clinical Trials in South Korea
  • Finding & Hiring CROs in South Korea
  • Clinical Trial Pharmacovigilance Reporting
  • Priority Reviews in South Korea
  • Cultural Aspects – Working in South Korea
  • CT Close-out and Reporting Requirements
  • Do’s and Don’ts, Practical Experiences Shared
  • Effectively Working with the Regulators
  • Wrap-Up Questions
  • Summary / Final Comments
• South Korea Regulatory Compliance
  
  • South Korea’s Regulatory Agencies Structure and Responsibilities
  • Overview of South Korea’s Healthcare System
  • Agency Review Process for Decision-Making
  • South Korean Drug Development Process
  • Requirements for Conducting Clinical Research
  • Country Establishment Licensing & Procedures
  • Requirements for Clinical Trials in South Korea
  • South Korea and ICH (International Conference on Harmonization)
  • How South Korea Wants to be Involved in Clinical Trials
  • South Korea’s Desire for Innovative Products
  • Conducting Meetings with the Agency
  • The Changing KFDA
  • How to Apply for Clinical Trials in South Korea; the CTA
  • Korean Philosophy in Risk Evaluation
  • Amending the CTA

Who should Attend

• Clinical / Pharma & Device personnel
• Regulatory Compliance personnel
• Monitors / CRAs
• Clinical Trial Project Managers
• Pharmacovigilance reporting personnel
• QA / QC Personnel
• Global Supply Chain personnel
• Regulatory personnel whose responsibilities require knowledge of Japan`s and South Korea’s Regulatory and Clinical Trial environment
• Global Business Development personnel
• Manufacturing personnel