Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

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.

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.

Learning Objectives: This course is designed to provide an overview of the regulatory environment in Japan and will provide training in:

• What is the Regulatory Structure in Japan
• Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
• How to begin your company involvement in Japan
• How current regulations effect product development strategies
• Pricing issues
• Understanding the concerns/issues of Japanese Regulatory Personnel
• Understanding the Local Culture: How to negotiate with the regulators
• Information necessary for effective submissions
• Maintenance of Authorized Products

• 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)
• Beginning Your Company Involvement in Japan
  • Local Office and Personnel Requirements
  • License Types
  • Overseas Manufacturers
• Life Science Regulations and the Regulatory Processes in Japan
  • Pre-Clinical
  • Conducting Clinical Trials
  • New Product Registrations & Filings
  • Adverse Drug Reactions
  • Post-Marketing Requirements
  • Maintenance of Licensed Products
  • Reimbursement, Audits
  • Risk Management
• Japan's Use of ICH Standards/Principles
• Marketing Authorization Processes - Filings & Registrations
  • Drugs, Medical Devices, Biologics
  • Similar Products & Devices
  • Labelling Requirements
  • PIL
• Variations: Changes to Marketed Products
• Renewals
  • Cultural Issues
  • How and When to Influence the Regulatory Process
• The Do's and Don'ts of Regulatory Involvement

• 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