Online Registration has been closed.
If you would registrate this, please contsct to DIA Japan. (japan@diaglobal.org)

Click here to view the Program.

In recent years, conducting multinational clinical studies has become an important drug development strategy to support simultaneous submission and approval of Marketing Applications in multiple markets. This strategic change requires expanding the scope of knowledge for professionals responsible for drug development. It is no longer sufficient to know only local pharmaceutical regulations and processes; it is now essential to be aware of global pharmaceutical regulations and trends.
This course will overview the US FDA regulations and expectations for the content, submission, and review of Investigational New Drug (IND) and New Drug Applications (NDAs) to the FDA. It is based on the annual IND/NDA training course conducted by DIA in the US, which is very popular with attendees from around the world, including participants from Japan. DIA has been presenting this course in Japan since 2012.
The training features:
• Focus on US regulations and processes (IND and NDA)
• How to work productively and efficiently with FDA
The course will be instructed by two of DIA’s original FDA/IND trainers in the US, Drs. Elliott Berger and Carol H Danielson. It will be conducted in English.

WHO SHOULD ATTEND?
This training will benefit regulatory and clinical development professionals in Japan who are intending or planning submissions to US FDA related to clinical trials or similar projects. This is an opportunity to receive in Japan the same training held in the US from the same instructors and using the same training materials. We hope you will take advantage of this opportunity.

Please note that the program is subject to change.