{"title":"从COVID-19危机中吸取的教训:与人体研究和产品授权相关的监管方面","authors":"Simone Ferbitz-Scheurer, Alexander Mion","doi":"10.54920/scto.2021.rawatch.5.15","DOIUrl":null,"url":null,"abstract":"The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"56 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation\",\"authors\":\"Simone Ferbitz-Scheurer, Alexander Mion\",\"doi\":\"10.54920/scto.2021.rawatch.5.15\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.\",\"PeriodicalId\":419230,\"journal\":{\"name\":\"Regulatory Affairs Watch\",\"volume\":\"56 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regulatory Affairs Watch\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.54920/scto.2021.rawatch.5.15\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Affairs Watch","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.54920/scto.2021.rawatch.5.15","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation
The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
