subject: Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GCPanel [print this page] Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GCPanel
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
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.
