Electronic common technical document

Results: 446



#Item
131Reference / Computer graphics / Standards / Graphics file formats / ISO standards / Electronic Common Technical Document / Portable Document Format / Document management system / Document file format / Computing / Computer file formats / Adobe Systems

Microsoft Word - iso032000-final-5apr11.docx

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Source URL: estri.org

Language: English - Date: 2012-06-05 01:13:02
132Checksum / Electronic Common Technical Document / MD5 / Cryptographic hash function / Cksum / Sum / Simple file verification / Computing / Software / Unix

Microsoft Word - File Security - MD5 v1_0-hwm.doc

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Source URL: estri.ich.org

Language: English - Date: 2012-06-04 19:13:02
133Research / Medical informatics / Electronic Common Technical Document / Computer file formats / Open formats / Computing / Clinical Data Management / Clinical research

ICH eCTD Specification VJuly-2008 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF

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Source URL: estri.org

Language: English - Date: 2012-06-05 01:13:00
134Computer graphics / Reference / Adobe Systems / Computer file formats / Clinical research / Electronic Common Technical Document / Portable Document Format / PDF/A / Open standard / ISO standards / Computing / Graphics file formats

EWG M2 Recommendation to the ICH Steering Committee Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF/A 2 June 2014 _______________________________________________

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Source URL: estri.org

Language: English - Date: 2014-06-13 11:26:25
135Computer file formats / XML / Technical communication / Document Type Definition / Electronic Common Technical Document / Efficient XML Interchange / Computing / Web standards / Markup languages

EWG M2 Recommendation to the ICH Steering Committee Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML 10NOV2005 Title: XML Background:

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Source URL: estri.ich.org

Language: English - Date: 2012-06-04 19:13:02
136Clinical Data Management / Electronic Common Technical Document / XML / Validation / Computing / Clinical research / Research

eCTD / NeeS Agenda Validation Rules Workshop Day 1 09:00 – 10:45 Theoretical Introduction

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Source URL: www.extedo.com

Language: English - Date: 2011-09-29 02:48:32
137Clinical Data Management / Clinical research / Electronic Common Technical Document

Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP (NAPs) Doc. Ref.: CMDh, Rev.2 February

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Source URL: www.hma.eu

Language: English - Date: 2015-03-10 10:40:36
138Research / Drug discovery / Pharmaceutical industry / Food and Drug Administration / Toxicology / Clinical trial / Drug development / Electronic Common Technical Document / Clinical pharmacology / Pharmacology / Pharmaceutical sciences / Clinical research

CLIII Consulting, LLC provides toxicology, non-clinical, and drug development consulting to the pharmaceutical, biotechnology, government, and academic communities on a global basis. Services include: • Scientific advi

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Source URL: www.actox.org

Language: English - Date: 2014-08-07 15:17:54
139Clinical research / Clinical Data Management / Medical informatics / Clinical trials / Electronic Common Technical Document / Title 21 CFR Part 11 / SDTM / Electronic submission / Electronic signature / Food and Drug Administration / Research / Medicine

Ensuring a Effective Submission Gary M Gensinger, MBA Director, Regulatory Review Support Staff Center for Drug Evaluation and Research

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Source URL: www.fda.gov

Language: English
140Clinical Data Management / Pharmaceutical industry / Medical informatics / Quality / Electronic Common Technical Document / Title 21 CFR Part 11 / Food and Drug Administration / Validation / Specification / Clinical research / Research / Medicine

eCTD Guidance Overview Gary M Gensinger, MBA Director, Regulatory Review Support Staff Center for Drug Evaluation and Research www.diahome.org

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Source URL: www.fda.gov

Language: English
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