ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use IMI Innovative Medicines Initiative IPPOSI Irish Platform for Patient Organisations, Science and Industry IRB/IEC Institutional Review Board/Independent Ethics Committee LS Lay Summary LPLV Last Participant/Patient Last Visit MDR Medical Device Regulation EU 2017/745 MedDRA Medical Dictionary for Regulatory Activities MRCT Multi-Regional Clinical Trials NAP National学院出版社PHRMA药物研究和美国PIS患者信息表QA质量保证质量保证QC质量控制研发研发研究与发展SAE严重不良事件SAR严重不良反应中小型企业中小型企业SOP SPERS SPENTPRISE SEP STARS STAR STARD STARD PRACEPTUR
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