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Food and Drug Administration / Science / Medical informatics / Medical statistics / Clinical Data Interchange Standards Consortium / SDTM / Clinical data acquisition / Electronic Common Technical Document / Clinical trial / Research / Clinical research / Clinical Data Management


Microsoft Word - Basic Policy on e-studysubmit for NDA.docx
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Document Date: 2015-05-12 07:05:08

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File Size: 55,82 KB

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Company

Welfare / Labour / Electronic Data Promotion Group / /

Country

Japan / /

Event

Person Communication and Meetings / Reorganization / /

IndustryTerm

individual products / subject products / electronic applications / pharmaceuticals regulatory affairs / Information management / present applications / /

MedicalCondition

disease / /

MusicAlbum

Culture / Technology / Sports / Science / /

Organization

Federation of Pharmaceutical Manufacturers / Task Force / Prefectural Health Department / Pharmaceuticals and Medical Devices Agency / FDA / CDISC / Evaluation and Licensing Division / Ministry of Education / Ministry of Health / Pharmaceutical and Food Safety Bureau / /

Position

physician / /

ProgrammingLanguage

XML / /

PublishedMedium

the Advanced Review / /

Technology

ADaM / pharmacokinetics / XML / IT technology / simulation / drug development / /

URL

http /

SocialTag