Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment 2012 is a seminar that covers topics such as:
- 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
Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment 2012 brings together:
- 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
