Common Technical Document

Results: 587



#Item
551Electronic Common Technical Document / Clinical research / Research / Clinical Data Management

Stakeholders’ Information 55th Heads of Medicines Agencies Meeting Hilton Arc De Triomphe Paris Hotel 6-7 November 2008 HMA – HUMAN Meeting The Heads of Medicines Agencies for human medicinal products met on 6 Novemb

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Source URL: www.hma.eu

Language: English - Date: 2008-11-13 12:51:21
552Technical communication / Archival science / Metadata / Markup languages / XML / Preservation Metadata: Implementation Strategies / METS / XML Schema / Database schema / Information / Data / Computing

Guidelines for using PREMIS with METS for exchange Revised September 17, 2008 This document offers guidance for using the PREMIS schema(s) as METS extensions. It is intended to suggest common practices for encoding METS

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Source URL: www.loc.gov

Language: English - Date: 2008-09-29 17:13:50
553Medicine / Clinical research / Drug safety / Pharmacovigilance / Pharmacy / MedDRA / Pharmaceutical industry / Electronic Common Technical Document / Biosimilar / Pharmacology / Pharmaceutical sciences / Research

Draft Report: IPRF 11 – 12 November 2013 Date: 22 November 2013 Draft Report International Pharmaceuticals Regulators Forum Meeting in Osaka, Japan; 11-12 November 2013

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Source URL: ec.europa.eu

Language: English - Date: 2014-05-05 07:48:07
554Clinical research / Pharmaceuticals policy / Medical informatics / Clinical Data Management / Clinical Data Interchange Standards Consortium / Prescription Drug User Fee Act / Abbreviated New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Electronic Common Technical Document / Food and Drug Administration / Medicine / Health

FDASIA  and   Standardized  Electronic  Data:     Where  Are  We?   FDA/PhUSE  Computational  Science  Symposium   Mary  Ann  Slack,  FDA/CDER     March  18,  2

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Source URL: www.phusewiki.org

Language: English - Date: 2013-05-29 09:36:05
555Research / Clinical Data Management / Minutes / Agenda / Electronic Common Technical Document / Meetings / Parliamentary procedure / Clinical research

[removed]April 2014 EMA/CMDh[removed]COORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES - HUMAN MEETING

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:55:48
556Medical informatics / Electronic Common Technical Document / Technology / Computing / Pharmaceutical industry / Common Technical Document / Electronic submission / Validation / Email / Clinical Data Management / Clinical research / Research

Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDh[removed]Rev2 April[removed]How to deal with National Translations of the Product Information Question 1.1

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:20:47
557Medical informatics / Electronic Common Technical Document / Computing / Technology / Pharmaceutical industry / Common Technical Document / Electronic submission / Validation / Email / Clinical Data Management / Clinical research / Research

Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDh[removed]Rev1Rev2 July 2013 April[removed]How to deal with National Translations of the Product Information

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:20:48
558Pharmaceutics / Pharmaceutical sciences / European Medicines Agency / Electronic Common Technical Document / Committee for Medicinal Products for Human Use / Medicines and Healthcare products Regulatory Agency / EMA / Validation / Email / Clinical research / Pharmaceutical industry / Research

21 May 2014 EMA[removed]Rev. 8 Dossier requirements for Centrally Authorised Products (CAPs) Submission of applications to the European Medicines Agency, Members of the Committee for Medicinal Products for Human use

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Source URL: www.ema.europa.eu

Language: English - Date: 2014-05-27 12:01:43
559Common Fisheries Policy / Economy of the European Union / Discards / Gillnetting / Fisheries management / Illegal /  unreported and unregulated fishing / Angling / Fishing tackle / Trawling / Fishing / Fishing industry / Fisheries science

European Anglers Alliance Consultation Response New Framework For Technical Measures In The Reformed Common Fisheries Policy May 2014 Introduction The following document represents the response by the European Anglers Al

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Source URL: ec.europa.eu

Language: English - Date: 2014-06-24 05:35:54
560Economy of the European Union / Directorate-General for Maritime Affairs and Fisheries / Common Fisheries Policy

European Commission: Directorate-General for Maritime Affairs and Fisheries, Directorate MARE. A [removed] Monday 19th May 2014 Commission Consultation Document: A new framework for technical m

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Source URL: ec.europa.eu

Language: English - Date: 2014-06-24 05:35:53
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