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

Day 1: Japan

Day 2: South Korea

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

Part I: South Korea Regulatory Compliance

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

Part II: Conducting Clinical Studies in South Korea

• Likely Parameters Defining Clinical Trials; What to Anticipate
• Clinical Trial Start-Up; ICH GCP and GMP Requirements
• Importing the IMP & Supplies into South Korea
• Product Labeling Requirements
• Finding & Hiring CROs in South Korea
• Conducting Clinical Trials in South Korea
• Priority Reviews in South Korea
• Clinical Trial Pharmacovigilance Reporting
• CT Close-out and Reporting Requirements
• Cultural Aspects – Working in South Korea
• Effectively Working with the Regulators
• Do’s and Don’ts, Practical Experiences Shared
• Summary / Final Comments
• Wrap-Up Questions

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.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.