C-CAST: Expedited Review Programs in Japan

(Please click the title to view the video. CMIC Group Website will open)

There are several effective expedited review programs in Japan. In this session, our expert introduced the process, criteria, and incentives of the following two key programs based on our experience.

・Orphan Drug Designation
・SAKIGAKE Designation

 

Speaker:

Koji Shikinami
Senior Regulatory Consultant, Consulting Division, CRO Business, CMIC Group

 

 

C-CAST: In-Country Clinical Caretaker (ICCC) for Clinical Trials in Japan

(Please click the title to view the video. CMIC Group Website will open)

Foreign sponsors without an entity in Japan needs to appoint an In-Country Clinical Caretaker (ICCC) in order to conduct a clinical trial. In this video, our two experts explained what ICCC is and the responsibilities ICCC holds.

Topics include:

・What is ICCC?
・Regulatory responsibilities
・Operational responsibilities

 

Speakers:
Koji Shikinami
Senior Regulatory Consultant, Consulting Division, CRO Business, CMIC Group

 

Miki Inui
Project Manager, Project Management Department, CRO Business, CMIC Group

 

 

*C-CAST is a mini-video series presented by CMIC Group. As the pioneer and leading CRO in Japan, we provide you with short and useful videos about pharmaceutical and healthcare industry, including educational contents, leader & expert interviews, and more. Watch the video and learn about the market/industry trend, latest regulatory information, and new technologies for your product development in the U.S., Japan, and broader Asia.

(Please click the banner to view the C-CASTs. CMIC Group Website "CMIC Resources" will open)