This Course covers the details on the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL]. The information presented 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.

This webinar will help you to prepare for regulatory approval processes, Agency meetings, the complexities of running clinical studies, the importance of partner selection and also add the cultural knowledge needed for success in-country. The recent changes made by PMDA to be more sponsor and applicant-friendly, along with the impact this has had on dossier review times, will be shared. Real world experiences on actual interactions with the Agency, since these changes have been implemented, will also be discussed.

Course Objectives:

Attendees will leave this Course clearly understanding the Regulatory Procedures necessary to be successful in getting your products to market in a timely fashion. This Course has been updated to provide participants with competitive insight into:

• The impact of the PAL to PMDL Law change to applicants
• Who can legally register Life Science products in Japan
• If you want to be the legal License holder, what will you need: establishment office & personnel type
• When will additional clinical trials be needed on products and on which ones
• Will Japan accept global, clinically-developed data
• How does a Japanese CTD submission differ from ICH requirements
• What is required to register a Medical Device in Japan
• Can you expect a GMP inspection of your facility by PMDA staff
• What are your post-marketing responsibilities as a License Holder
• How best to work with the Authorities from a Business and Cultural Aspect

Course Outline:

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)
               -Agency Consulting Committees

• Patent System
• Pharmaceutical Affairs Law (PAL) ? Pharmaceuticals & Medical Device Law (PMDL)

• 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 Japan
                -  Conducting Clinical Trials
                -  New Product Registrations
                -  Handling of Risk Management
                -  Post-Marketing Requirements: Variations / amendments, Safety Reporting, Renewals

• Japan’s Use of ICH Standards / Principles
                -  GCP
                -  GMP
                -  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  / Device 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

• How and When to Influence the Regulatory Process
                   - The Do’s and Don’ts of Regulatory Involvement in Japan
                   - Utilizing Local Regulatory Resources

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Clinical Operations Staff
• Quality Assurance
• Monitors / CRAs
• Regulatory Affairs Personnel
• Pharmacovigilance Reporting personnel
• Global Supply Chain personnel
• Manufacturing personnel
• Global Business Development personnel
• Country Managers
• CRO’s, Consultants