Japan Regulatory Compliance Requirements for Life Science Products Seminar

Global Compliance Seminars

This 2-Day seminar covers the details of 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] and the country's latest update to GMP requirements.

Course Description

Course "Japan Regulatory Compliance Requirements for Life Science Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2-Day seminar covers the details of 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] and the country's latest update to GMP requirements.

The information presented will help you gain a comprehensive understanding of the Regulatory Structure, Product Classification, Clinical Trial Requirements, Marketing Authorization Procedures, Variations Processing, License Renewals, GMP requirements and cultural working aspects within the Regulatory Environment in Japan. It will prepare you 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 Objective:
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
- Japan's Medical Device classification procedures and regulatory pathways
- Can you expect a GMP inspection of your facility by PMDA staff; updates to GMP Regulation & Guidelines
- What are your post-marketing responsibilities as a License Holder
- How best to work with the Authorities from a Business and Cultural Aspect
Who will benefit:
This seminar will benefit Project Team Members, whose specific functional discipline comes from:
- Clinical Operations Staff
- Quality Assurance
- Monitors / CRAs
- Regulatory Affairs Personnel
- Pharmacovigilance Reporting personnel
- Global Supply Chain personnel
- Manufacturing personnel
- Global Business Development personnel
- Commercial Management
- Country Managers
- CRO's, Consultants

Agenda:

Day 1 Schedule

Part I: Japan Regulatory Compliance

Lecture 1:

Japan's Regulatory Structure for the Life Science Product Industries

Country Healthcare System
Regulatory Framework: Key Agencies Involved / Reporting Structure
- MHLW (Ministry of Health, Labor and Welfare)
- PMDA (Pharmaceutical and Medical Device Agency)
- Agency Consulting Committees
Patent System
Pharmaceutical Affairs Law (PAL) → Pharmaceuticals & Medical Device Law (PMDL)

Lecture 2:

Beginning Your Company Involvement in Japan

Local Office and Personnel Requirements
Language Requirements & Translations
License Types
Options for Importers / Overseas Manufacturers

Lecture 3:

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

Lecture 4:

Japan's Use of ICH Standards / Principles

GCP
GMP
CTD / e-CTD Submissions

Lecture 5:

Starting-Up and Conducting Clinical Trials

Who can conduct Clinical Trials?
When are they needed?
Start-up Process & Timelines

Day 2 Schedule

Part II:

Lecture 1:

Marketing Authorization Processes - Product Registrations / Licensing

Drugs
Medical Devices
Biologics
Combination Products
Drug / Device Master File (DMF) Use in Japan
Labeling Requirements
Packaging Information Leaflets

Lecture 2:

Variations: Changes to Marketed Products

Types of Variations & Dossier Maintenance Expectations

Lecture 3:

License Renewals

Process and timing for Renewing Licenses

Lecture 4:

Comparing and Contrasting Japan's Procedures vs. U.S. FDA

Comparison of Processes
Expected Timelines

Lecture 5:

How and When to Influence the Regulatory Process

The Do's and Don'ts of Regulatory Involvement in Japan
Utilizing Local Regulatory Resources

Speaker:

Robert Russell

President / CEO , RJR Consulting, Inc.

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Credits Available

More Seminar Information

Global Compliance Panel
Summary	This 2-Day seminar covers the details of 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] and the country's latest update to GMP requirements.
Delivery Method	Seminar
Who Should Attend	Clinical Operations Staff, Quality Assurance, Monitors / CRAs, Regulatory Affairs Personnel, Pharmacovigilance Reporting personnel, Global Supply Chain personnelManufacturing personnel, Global Business Development personnel, Commercial Management, Country Managers, CRO's, Consultants