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
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
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
Variations: Changes to Marketed Products
Cultural Issues
How and When to Influence the Regulatory Process
The Do's and Don'ts of Regulatory Involvement

Who Will Benefit:

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

Quick Contact:

USA Phone:800-447-9407
Event Link - http://bit.ly/1lts0cT