ComplianceOnline

Japan - Regulatory Requirements and Compliance Processes for Life Science Products - Part II

Instructor: Robert J Russell
Product ID: 701534
  • Duration: 90 Min

recorded version

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Training CD

$700.00
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Read Frequently Asked Questions

This Webinar will discuss the Marketing Authorization Processes – Filings & Registrations in Japan. How and when to influence the regulatory process and how to use regulations to your advantage.

Why Should You Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will address the structure of the regulatory agencies in Japan. Content will include Marketing Authorization Process by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques as compared to US FDA. Common issues which have caused difficulties for Life Sciences firms will also be discussed. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution, how and when to interact with regulatory agencies.

This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one’s Business Strategy.

Areas Covered in the seminar:

  • Marketing Authorization Processes – Filings & Registrations
    • Pharmaceutical Affairs Law (PAL) & Drug Registration
    • Medical Devices
    • Biologic Considerations
    • Developing Combination Products; Classification and Licensing Review
    • Drug Master File (DMF) Use in Japan
    • Labeling Requirements
    • Package Insert Requirements
  • Variations: Changes to Marketed Products
    • Types of Variations
    • Variation Filings and Typical Review Times
  • License Renewals
    • Japan’s Process; What has recently changed?
    • License Terms
    • Maintenance Responsibilities
  • 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 / Coming to Agreement
    • Important Cultural Issues for Consideration
    • The Do’s and Don’ts of Regulatory Involvement in Japan
  • How to Use Regulations / Regulatory Contacts to Your Advantage
      • Agency Interactions
      • Business Impact Within and Outside of Japan
      • Professionalism in Regulatory Affairs

Who will benefit:

This course will be of benefit to:

  • Regulatory personnel whose responsibilities require knowledge of Japan’s regulatory environment
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements
  • Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization

Instructor Profile:
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.

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