Overview: 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.
Agenda for Part I:
Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products - Japan`s Regulatory Structure for the Life Science Product Industries
- Demographic Overview
- Regulatory Framework: Key Agencies Involved / Reporting Structure
- Recent Changes to MHLW / PMDA to Speed Review
- MHLW (Ministry of Health, Labour and Welfare)
- PMDA (Pharmaceutical and Medical Device Agency)
- PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
- Patents and Trademark Considerations
- Beginning Your Company Involvement in Japan
- Local Office and Personnel Requirement Options
- Language Requirements
- Possible License Types
- 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
- Post-Marketing Requirements
- Pricing & Reimbursement
- Japan`s Use of ICH Standards / Principles
- GCP
- GMP
- CTD / e-CTD Submissions
- Starting-Up and Conducting Clinical Trials
- Clinical Trial Start-Up process
- Japan`s Effort to Reduce "The Drug Lag"
- Japan`s Desire to Eliminate Bridging Studies and Participate in Ph. III Global Trials
Agenda for Part II:
Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products - 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 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.
