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Regulatory Compliance Training in Japan

In this four-hour virtual seminar, participants will gain valuable insights into Japan’s overall regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics, and combination products. The training will cover topics relating to pre-clinical and clinical requirements, as well as the structure of the regulatory agencies in Japan.

Why Attend

This comprehensive training is designed to provide a detailed overview of the regulatory requirements, local challenges, and important cultural aspects of working with life science products in Japan. Participants will learn how to navigate the complex regulatory landscape, including the specific procedures for pharmaceuticals, medical devices, biologics, and combination products.

Learning Objectives

  • Understand Japan’s regulatory structure and key agencies involved
  • Learn about local licenses, personnel, and facilities required for market authorization holder overview
  • Gain insights into pre-clinical and clinical requirements, as well as post-marketing requirements
  • Discover the methods by which regulators in MHLW/PMDA process filings and registrations
  • Learn about Japan’s use of ICH standards/principles, including GCP, GMP, and CTD/e-CTD submissions
  • Understand the marketing authorization processes for pharmaceuticals, medical devices, biologics, and combination products
  • Gain knowledge on variations: changes to marketed products and renewals

Who Will Benefit

This training is designed for:

  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing/production staff
  • Global business development professionals
  • Senior management
  • Administrative staff responsible for ensuring compliance with regulatory filings
  • General management requiring an understanding of Japan’s regulatory requirements

Instructor Profile

Robert J. Russell, President and CEO of RJR Consulting, Inc., has over 27 years of experience in product development, global business development, and regulatory compliance for pharmaceuticals, medical devices, consumer products, food, and cosmetics manufacturers. His expertise includes:

  • Country establishment
  • Product licensing and maintenance
  • License renewals

Course Agenda

  1. Japan’s Regulatory Structure for the Life Science Product Industries
  2. Beginning Your Company Involvement in Japan
  3. Objectives of the Rules Governing Medicinal Procedures
  4. Life Science Regulations and the Regulatory Processes in Japan
  5. Japan’s Use of ICH Standards/Principles
  6. Starting-Up and Conducting Clinical Trials
  7. Marketing Authorization Processes – Filings & Registrations
  8. Variations: Changes to Marketed Products
  9. Renewals
  10. Comparing and Contrasting Japan’s Procedures vs. U.S. FDA
  11. How and When to Influence the Regulatory Process