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
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 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
Robert J. Russell For the past 9 years, He has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America.