Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I & PART II

With the 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL), foreign life science companies are eyeing on the opportunities created in Japanese market for them. It becomes imperative to understand the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

ComplianceOnline brings to you a pack of 2 modules which will give you an indepth understanding of topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Part 1:

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

Areas Covered in the Webinar:

• Japan's Regulatory Structure for the Life Science Product Industries.
  • Demographic
  • Regulatory Framework: ?Key Agencies Involved / Reporting Structure
  • MHLW (Ministry of Health, Labour and Welfare)
  • PMDA (Pharmaceutical and Medical Device Agency)
  • PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
  • Patents
• Beginning Your Company Involvement in Japan.
  • Local Office and Personnel Requirements.
  • Language Requirements
  • License Types
  • Overseas Manufacturers
• Objectives of the Rules Governing Medicinal Procedures.
• Market Authorization Holder Overview.
  • Life Science Regulations and the Regulatory Processes in Japan
  • Pre-Clinical
  • Conducting Clinical Trials
  • New Product Registrations & Filings
  • Adverse Drug Reactions
  • Post-Marketing Requirements
  • Reimbursement, Audits
  • Risk Management
• Japan's Use of ICH Standards / Principles.
  • GCP
  • GMP
  • Quality Documents and Standards
  • CTD / e-CTD Submission

Part 2:

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.

Areas Covered in the Webinar:

• Starting-Up and Conducting Clinical Trials.
• CRO Concept in Japan.
• Clinical Trials vs. Clinical Investigations.
• Marketing Authorization Processes - Filings & Registrations.
  • Drugs
  • Pharmaceutical Affairs Law (PAL)
  • Medical Devices
  • Biologics
  • Combination Products
• Drug Master File (DMF) Use in Japan
• Labeling Requirements.
  • PIL
• Variations: Changes to Marketed Products.
  • Types of Variations
  • Dossier Maintenance Expectations
• Renewals
• Comparing and Contrasting Japan's Procedures vs. U.S. FDA.
  • Comparison of Processes
  • Agency Interactions
  • Accepted Practices
• How and When to Influence the Regulatory Process.
  • Japanese Way of Thinking
  • Cultural Issues
  • Effective Approaches
  • The Do's and Don'ts of Regulatory Involvement
• How to Use Regulations / Regulatory Contacts to Your Advantage.
  • Check-in Procedure
  • Agency Interactions
  • Business Impact Within and Outside Japan
  • Professionalism in Regulatory Lobbying

Panelist Profiles:
Robert J. Russell, For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.