Who Should Attend
This course will be of benefit to 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.
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 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
- Strategies for streamlining the registration application process for faster approval
- Maintenance of Authorized Products
Course Description
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.
View Course Agenda
Past Participant's Comments
“I appreciate the comprehensive overview of Japanese regs. The Course Director was extremely knowledgeable and was willing to answer questions.”
Patti K., Manager, FDA Regulatory Affairs, Dow Corning
“The glossary of terms cheat sheet is really nice. The information covered was very extensive. I really enjoyed the fact that there were people from multiple departments and backgrounds in the class.”
Brook C., Sr. Manager, Global Regulatory Strategies, Thompson Scientific
“I attended a Japanese Regulations course by another company about a year ago. This CfPIE class is much better than the class I attended with a competitor. They discussed cultural issues and not enough about the registration and renewal process. I am very pleased with this course and will definitely recommend it to my peers.”
Anonymous
“Very comprehensive and well paced.”
David F., Director, International Quality, Amgen
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