Electronic common technical document

Results: 446



#Item
181Pharmaceutical industry / Pharmacology / Medicine / Drug safety / Pharmacy / Pharmacovigilance / Validation / Electronic Common Technical Document / Clinical research / Pharmaceutical sciences / Research

AD HOC WORKING GROUP ON VALIDATION ISSUES/NATIONAL REQUIREMENTS CMDh PROCEDURAL ADVICE ON COMMON GROUNDS SEEN FOR DELAYING DAY 0 RENEWALS

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Source URL: www.hma.eu

Language: English - Date: 2013-01-24 09:52:40
182Electronic Common Technical Document / Competitions / Digital media / Electronic submission / Audio power / Technology / Scientific method / Science / Clinical Data Management / Clinical research / Medical informatics

DOC Document

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Source URL: www.hma.eu

Language: English - Date: 2012-07-02 09:21:23
183Research / Medical informatics / Clinical Data Management / GlobalSCAPE / Pharmacy / Electronic Common Technical Document / AS2 / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences / Clinical research / Pharmacology

TM Use Case e-Submissions Follow Extensive Medical Regulations with Large File Exchange

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Source URL: www.globalscape.com

Language: English - Date: 2015-01-03 17:49:01
184Research / Health Level 7 / Electronic Common Technical Document / Medical informatics / Health / Medicine

ICH M8 EWG/IWG Work Plan 30 August 2014 Topic Adopted: 11 November 2010 Last Face-to-Face Meeting: Minneapolis, MN, USA – June[removed]Anticipated Milestones

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Source URL: www.ich.org

Language: English - Date: 2014-09-17 09:58:06
185Clinical Data Management / Health / Drug safety / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Electronic Common Technical Document / MedDRA / Environmental Working Group / Clinical trial / Clinical research / Research / Pharmacology

16 September[removed]MEETING REPORT ICH Steering Committee 4 – 5 June 2014, Minneapolis, MN, USA

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Source URL: www.ich.org

Language: English - Date: 2014-09-16 12:20:13
186Research / Structured Product Labeling / Center for Biologics Evaluation and Research / Adverse Event Reporting System / Validation / Electronic Common Technical Document / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Title 21 CFR Part 11 / Food and Drug Administration / Medicine / Health

Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b

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Source URL: www.fda.gov

Language: English
187Research / Structured Product Labeling / Center for Biologics Evaluation and Research / Adverse Event Reporting System / Validation / Electronic Common Technical Document / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Title 21 CFR Part 11 / Food and Drug Administration / Medicine / Health

Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b

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Source URL: www.fda.gov

Language: English
188Clinical Data Management / Health / Drug safety / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Electronic Common Technical Document / MedDRA / Environmental Working Group / Clinical trial / Clinical research / Research / Pharmacology

16 September[removed]MEETING REPORT ICH Steering Committee 4 – 5 June 2014, Minneapolis, MN, USA

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Source URL: www.ich.org

Language: English - Date: 2014-09-17 03:26:13
189Health / Clinical research / Clinical Data Management / Drug safety / Medical informatics / Electronic Common Technical Document / Prescription Drug User Fee Act / Common Technical Document / Investigational New Drug / Medicine / Research / Food and Drug Administration

PDUFA V Final IT Plan[removed]All Edits[removed])

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Source URL: www.fda.gov

Language: English
190Clinical research / Medical informatics / Pharmacology / Food and Drug Administration / Clinical Data Management / Clinical Data Interchange Standards Consortium / Center for Biologics Evaluation and Research / Electronic Common Technical Document / Adverse Event Reporting System / Pharmaceutical sciences / Research / Medicine

CDER Data Standards Strategy Action Plan

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Source URL: www.fda.gov

Language: English
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