Who Should Attend This course will benefit regulatory personnel whose responsibilities require knowledge of
Japan’s regulatory environment. Administrative staff charged with ensuring compliance with regulatory filings and overall regulatory mandates will also find this training highly relevant. Additionally, any sales or general management personnel requiring an understanding of how regulations and compliance issues impact the organization will find the course useful.
Learning Objectives
This course is designed to provide an overview of the regulatory environment in Japan and will provide training in:
- 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 Pharmaceutical, Medical Device, Biologic and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of Japanese regulatory agencies. Content will 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 Science firms will also be discussed. Course content will explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution.
Additionally, this course will 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.