Regulatory Affairs Watch最新文献

筛选
英文 中文
Patient-to-patient: Talking about medical devices 病人对病人:谈论医疗设备
Regulatory Affairs Watch Pub Date : 2019-10-01 DOI: 10.54920/scto.2019.rawatch.2.16
{"title":"Patient-to-patient: Talking about medical devices","authors":"","doi":"10.54920/scto.2019.rawatch.2.16","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.16","url":null,"abstract":"How will the regulatory changes taking place for medical devices affect patients – those who carry the true risks or benefits of having them in or on their bodies? For a down-to-earth patient perspective, European Patients’ Academy (EUPATI) fellow Estelle Jobson met with Karen Topaz Druckman, President of the Swiss patient association, HHT Swiss, to ask her some questions. Karen’s views represent years in patient advocacy including patient input.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128166378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What about software used in human research? 那用于人类研究的软件呢?
Regulatory Affairs Watch Pub Date : 2019-10-01 DOI: 10.54920/scto.2019.rawatch.2.18
Claudia Becherer
{"title":"What about software used in human research?","authors":"Claudia Becherer","doi":"10.54920/scto.2019.rawatch.2.18","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.18","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131653981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medical devices: Regulatory environment forecasts 医疗器械:监管环境预测
Regulatory Affairs Watch Pub Date : 2019-10-01 DOI: 10.54920/scto.2019.rawatch.2.3
Mariagrazia Di Marco, Laure Vallotton
{"title":"Medical devices: Regulatory environment forecasts","authors":"Mariagrazia Di Marco, Laure Vallotton","doi":"10.54920/scto.2019.rawatch.2.3","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.3","url":null,"abstract":"The regulatory landscape of medical devices is currently undergoing tremendous changes in the EU – changes that will directly affect Switzerland. Following numerous serious incidents resulting from medical devices (most notably, hip prostheses and defective silicone breast implants), a searchlight has been cast on the manufacturing, marketing, and surveillance of medical devices, as they stand in the EU. The systems in place contained many loopholes and shortcuts, which allowed some poor-quality and risk-compromising devices to be authorised. Consequently, the EU decided to tighten the regulatory procedures and two new EU regulations entered into force in 2017. They will apply, starting in 2020 and 2022, respectively. These changes set out in the regulations seek to improve medical device safety and performance and will carry consequences in terms of clinical evaluations and investigations on the devices, and how they are conducted. Switzerland is currently adapting its legislation on medical devices, to ensure that Swiss-based patients will also benefit from the improvements made. At the same time, only by aligning its own legislation to EU developments, will Switzerland be able to maintain its position as an equal partner in the EU internal market for medical devices. Nevertheless, some issues still need to be solved urgently for a smooth transition to take place.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115386697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EU GDPR: Views and Opinions 欧盟GDPR:观点和意见
Regulatory Affairs Watch Pub Date : 2019-04-01 DOI: 10.54920/scto.2019.rawatch.1.4
{"title":"EU GDPR: Views and Opinions","authors":"","doi":"10.54920/scto.2019.rawatch.1.4","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.1.4","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"164 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134430929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The European General Data Protection Regulation (GDPR): Interactions with clinical research 欧洲通用数据保护条例(GDPR):与临床研究的相互作用
Regulatory Affairs Watch Pub Date : 2019-04-01 DOI: 10.54920/scto.2019.rawatch.1.2
{"title":"The European General Data Protection Regulation (GDPR): Interactions with clinical research","authors":"","doi":"10.54920/scto.2019.rawatch.1.2","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.1.2","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133906981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信