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

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:

• 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 Submissions.

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.

Follow us :