Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-5
Annie Joseph
{"title":"Commercial Sense and What It Means for a Regulatory Manager or Executive","authors":"Annie Joseph","doi":"10.1201/9781003207696-5","DOIUrl":"https://doi.org/10.1201/9781003207696-5","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48130915","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-10
R. Peeling, David Heymann, N. Fongwen, O. Williams, Joanna Wiecek, Phil Packer, G. Juarez-Martinez
{"title":"Accelerating Access to in vitro Diagnostics: Urgent Need for Increasing the Speed and Efficiency of Regulatory Review and Policy Development for in vitro Diagnostics for Antimicrobial Resistance and Epidemic Preparedness and Response","authors":"R. Peeling, David Heymann, N. Fongwen, O. Williams, Joanna Wiecek, Phil Packer, G. Juarez-Martinez","doi":"10.1201/9781003207696-10","DOIUrl":"https://doi.org/10.1201/9781003207696-10","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46915626","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-19
Gabriel Ehrlich
{"title":"Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance","authors":"Gabriel Ehrlich","doi":"10.1201/9781003207696-19","DOIUrl":"https://doi.org/10.1201/9781003207696-19","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47526597","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-51
A. Chan
{"title":"A Regulatory Career in Asia","authors":"A. Chan","doi":"10.1201/9781003207696-51","DOIUrl":"https://doi.org/10.1201/9781003207696-51","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47654382","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-39
Pei-Weng Tu
{"title":"Taiwan: Medical Device Regulatory System Introduction","authors":"Pei-Weng Tu","doi":"10.1201/9781003207696-39","DOIUrl":"https://doi.org/10.1201/9781003207696-39","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44308708","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-45
V. Chan
{"title":"Leading the New Normal by Accelerating Digital Transformation","authors":"V. Chan","doi":"10.1201/9781003207696-45","DOIUrl":"https://doi.org/10.1201/9781003207696-45","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41445142","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}
Medical affairsPub Date : 2021-11-25DOI: 10.1201/9781003207696-18
T. Chan, Raymond K. Y. Tong
{"title":"ISO 14971: Application of Risk Management to Medical Devices","authors":"T. Chan, Raymond K. Y. Tong","doi":"10.1201/9781003207696-18","DOIUrl":"https://doi.org/10.1201/9781003207696-18","url":null,"abstract":"","PeriodicalId":78432,"journal":{"name":"Medical affairs","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47144041","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}