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Regulatory Related Activities

In order to 1) conduct high standard international collaborative clinical trials that comply with regulations in Asia and 2) accelerate regulatory approvals, it is essential to collaborate not only with academia but also with regulatory authorities in each country.
For this reason, we organize symposiums in cooperation with the Pharmaceuticals and Medical Devices Agency (PMDA; Japanese regulatory agency) and other regulatory authorities in the Asian countries, as well as the Japan Pharmaceutical Manufacturers Association (JPMA) and other associations.
The symposium is designed to help participants understand the regulatory requirements for clinical trials in Asia, and to discuss how to achieve early access to pharmaceuticals and medical devices.

The 1st ARISE-PMDA Joint Symposium for Asian Clinical Trial

The 2nd ARISE-PMDA Joint Symposium for Asian Clinical Trial