Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation.
Kenichi NakamuraHitoshi OzawaTaro ShibataNobuko UshirozawaTomomi HataNatsuko OkitaNozomu FuseNorihiro SatoKoji IkedaHideki HanaokaTatsuya MaruyamaMichihiko WadaShinobu ShimizuHiroi KasaiYoichi YamamotoJun SakuraiKoji TodakaShimon TashiroHaruko YamamotoPublished in: Therapeutic innovation & regulatory science (2021)
The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.