Perspectiva general

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.

Temas destacados

- 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

¿Quiénes deben asistir?

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

Objetivos de aprendizaje

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

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

Perspectiva general

Temas destacados

¿Quiénes deben asistir?

Objetivos de aprendizaje

Be informed and stay engaged.