GPMSP (good post-marketing surveillance practice)医薬品の市販後調査の基準GPSP (good post-marketing study practice)医薬品の製造販売後の調査及び試験の実施の基準GVP (good vigilance practice)医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準
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LEXICON
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G1/G2 RuleG1/G2ルールMarch 9, 2018
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New PMP Criteria新薬創出加算の新要件March 9, 2018
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Cost-Based Method原価計算方式July 27, 2017
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Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
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Special expansion re-pricing (Huge-seller re-pricing)特例拡大再算定(巨額再算定)March 4, 2016
The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…
The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…
By managing personal bias during the interview process, hiring managers can significantly improve their hit rate placing winning candidates. The trouble is, it’s easier said than done. It’s only natural we tend to like people we can relate to, people…