Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

This on-demand course reviews significant changes in Japanese pharmaceutical regulations and procedures which impacts the development of new drugs in Japan as well as global development programs.  Regulatory framework and reform as well as drug development processes and pathways will be highlighted.  The use of real-world evidence and data for regulatory decisions in Japan will also be covered.

This on-demand course takes 3 hours to complete. Learners have access to the course for one year from the date of purchase.

• Japanese pharmaceutical market
• Pharmaceutical regulatory framework in Japan
• The "drug lag:" A driver of regulatory reform
• The drug development, consultation, and approval process
• Special programs and accelerated pathways
• Use of real-world evidence (RWE) and real-world data (RWD) for regulatory decisions in Japan

This on-demand course is designed for professionals involved in global development projects involving Japan including those who work in:

• Regulatory Affairs
• Project Management
• Clincial Development

At the conclusion of this course, participants should be able to:

• Determine the major elements of the Japanese regulatory system
• Identify the regulatory procedures during development, registration, and post-approval
• Recognize specific attributes of the Japanese regulatory system and their impact on local and global development strategies