What you will learn
- To understand the Japanese drug development and post-approval framework and regulatory procedure
- The do’s and don’ts of constructive interactions with Japanese colleagues and officials
- How to successfully navigate the PMDA consultations
- How to play an important role in any project team working on obtaining a marketing authorization in Japan
What your company will get
- An employee who understands the Japanese drug development, post-approval framework and regulatory procedures
- A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
- A regulatory professional who is able to successfully navigate the PMDA consultations
- A regulatory professional who can play an important strategic role in project teams working on obtaining a marketing authorization in Japan