2022.02.08 Part11 FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
2020.02.23 EUにおける医療機器規制(MDR/IVDR) Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a 'person responsible for regulatory compliance'(PRRC)
2021.04.16 FDA 【対訳版】Remote Interactive Evaluations of Drug Manufacturing Establishments(COVID-19 公衆衛生緊急事態中の医薬品製造及び バイオリサーチモニタリング施設の リモートインタラクティブ評価 業界向けガイダンス)