This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
This webinar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor and applicant-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes were implemented, will also be discussed.
Course Agenda/Areas Covered:
Why Should You Attend:
If your job responsibilities require you to have knowledge of Japan’s regulatory requirements, ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements or understand how best to consider Japan into your Global Business Strategy, then you will profit from attending our training.This webinar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals and cultural working aspects within the Regulatory Environment in Japan. It will prepare you for regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and will also add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor and applicant-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes were implemented, will also be discussed.
Course Agenda/Areas Covered:
- Part I: Japan Regulatory Compliance
Japan’s Regulatory Structure for the Life Science Product Industries
- Country Healthcare System
- Regulatory Framework: Key Agencies Involved/Reporting Structure
- MHLW (Ministry of Health, Labour and Welfare)
- PMDA (Pharmaceutical and Medical Device Agency)
- MoH Consulting Committees
- Consensus Decision-Making: Strengths, Timeline Impacts
- Patent System
- Pharmaceutical Affairs Law (PAL)
Beginning Your Company Involvement in Japan
- Local Office and Personnel Requirements
- Language Requirements
- License Types
- Options for Importers/Overseas Manufacturers
Objectives of the Rules Governing Medicinal Procedures
- Life Science Regulations and the Regulatory Processes in Japa
- Conducting Clinical Trials
- New Product Registrations
- Handling of Risk Management
- Variations to Licenses
- Post-Marketing Requirements
- License Renewals
Japan’s Use of ICH Standards/Principles
- GCP
- GMP
- Quality Documents and Standards
- CTD/e-CTD Submissions
- Starting-Up and Conducting Clinical Trials
- Who can conduct Clinical Trials?
- When are they needed?
- Start-up Process & Timelines
Part II: Marketing Authorization Processes - Product Registrations/Licensing
- Drugs
- Medical Devices
- Biologics
- Combination Product
- Drug Master File (DMF) Use in Japan
- Labeling Requirements
- Packaging Information Leaflets
Variations: Changes to Marketed Products
- Types of Variations
- Dossier Maintenance Expectations
License Renewals
- Process and timing for Renewing Licenses
Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
- Comparison of Processes
- Expected Timelines
- Accepted Practices
How and When to Influence the Regulatory Process
- Japanese Way of Thinking/Cultural Issue
- Effective Approaches to Meet Regulators
- The Do’s and Don’ts of Regulatory Involvement in Japan
- Utilizing Local Regulatory Resources
- Recently Asked Questions:
- What determines if a notification needs to be sent to the PMDA if there is a change to the product? There have been no decision trees released by Japan unlike the US and Canada.
Who Will Benefit:
- 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
Course Content
Part I: Japan Regulatory Compliance- Japan’s Regulatory Structure for the Life Science Product Industries
- Country Healthcare System
- Regulatory Framework: Key Agencies Involved / Reporting Structure
- MHLW (Ministry of Health, Labour and Welfare)
- PMDA (Pharmaceutical and Medical Device Agency)
- MoH Consulting Committees
- Consensus Decision-Making: Strengths, Timeline Impacts
- Patent System
- Pharmaceutical Affairs Law (PAL)
- Beginning Your Company Involvement in Japan
- Local Office and Personnel Requirements
- Language Requirements
- License Types
- Options for Importers / Overseas Manufacturers
- Objectives of the Rules Governing Medicinal Procedures
- Life Science Regulations and the Regulatory Processes in Japa
- Conducting Clinical Trials
- New Product Registrations
- Handling of Risk Management
- Variations to Licenses
- Post-Marketing Requirements
- License Renewals
- Japan’s Use of ICH Standards / Principles
- GCP
- GMP
- Quality Documents and Standards
- CTD / e-CTD Submissions
- Starting-Up and Conducting Clinical Trials
- Who can conduct Clinical Trials?
- When are they needed?
- Start-up Process & Timelines
Part II: Marketing Authorization Processes – Product Registrations / Licensing
- Drugs
- Medical Devices
- Biologics
- Combination Product
- Drug Master File (DMF) Use in Japan
- Labeling Requirements
- Packaging Information Leaflets
- Variations: Changes to Marketed Products
- Types of Variations
- Dossier Maintenance Expectations
- License Renewals
- Process and timing for Renewing Licenses
- Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
- Comparison of Processes
- Expected Timelines
- Accepted Practices
- How and When to Influence the Regulatory Process
- Japanese Way of Thinking / Cultural Issue
- Effective Approaches to Meet Regulators
- The Do’s and Don’ts of Regulatory Involvement in Japan
- Utilizing Local Regulatory Resources
Speaker
Robert J RussellCourse Provider
Robert J Russell,
