REGULATORY
Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
The Japanese health ministry is considering an amendment of its good clinical practice (GCP) ordinance with an eye towards incorporating the principle of a single institutional review board (IRB) per trial. The timeline for such changes is not yet determined.…
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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





