Japan: Regulatory Compliance Requirements for Life Science Products | Webinar

Topic ID: 000000199-web

Start Date: Sep 24, 2015

Start Time: 10 AM PST | 1 PM EST

Name of Event: Japan: Regulatory Compliance Requirements for Life Science Products | Webinar

Details: 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.

Areas Covered In The Session:

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. 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.

For more details call Complystream at: (+1) 844 498 6361