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

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 cover 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.

The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. 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.

Areas Covered in the seminar:

• 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.

Who will benefit:

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.

• 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 will also find this training highly relevant.
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.

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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