Electronic common technical document

Results: 446



#Item
301

Ébauche de la ligne directrice - Préparation des activités réglementaires des drogues en format Electronic Common Technical Document

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Source URL: www.hc-sc.gc.ca

Language: French - Date: 2013-07-09 17:16:49
    302International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Electronic Common Technical Document / Common Technical Document / MedDRA / Clinical trial / Pharmacopoeia / Clinical research / Research / Science

    Overview of ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Overview of ICH

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    Source URL: www.ich.org

    Language: English - Date: 2014-01-08 03:50:59
    303Science / Health / Pharmaceuticals policy / Drug safety / Clinical Data Management / Electronic Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / MedDRA / Environmental Working Group / Clinical research / Research / Pharmacology

    Microsoft Word - ICH SC Meeting Yokohama 2009_Without URL.doc

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    Source URL: www.ich.org

    Language: English - Date: 2012-06-21 10:46:45
    304Health / Pharmaceutical industry / Clinical research / Japan Pharmaceutical Manufacturers Association / Pharmacy / Good manufacturing practice / Electronic Common Technical Document / Daiichi Sankyo / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Pharmaceuticals policy / Pharmaceutical sciences / Pharmacology

    Tokyo ICH Symposium: Hot Topics and influence on Asia

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    Source URL: www.ich.org

    Language: English - Date: 2013-10-29 11:16:09
    305Technology / Clinical Data Management / Pharmaceutical industry / Pharmaceuticals policy / Drug safety / Electronic Common Technical Document / Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Drug Master File / Medicine / Clinical research / Research

    Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format

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    Source URL: www.hc-sc.gc.ca

    Language: English - Date: 2013-07-09 17:16:48
    306Pharmaceutics / Pharmaceutical sciences / Clinical Data Management / Pharmacology / Pharmaceuticals policy / Electronic Common Technical Document / MUT / Common Technical Document / MedDRA / Pharmaceutical industry / Clinical research / Research

    Microsoft Word - GCG140F Final Report GCG_Meeting_Cincinnati_June 2011.docx

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    Source URL: www.ich.org

    Language: English - Date: 2012-06-21 12:43:52
    307Medicine / Medical informatics / Electronic Common Technical Document / Food and Drug Administration / Common Technical Document / Health Canada / Portable Document Format / Clinical trial / Regulated Product Submissions / Clinical research / Research / Clinical Data Management

    ISSUE ANALYSIS SUMMARY Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format Published by authority of the Minister of Health

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    Source URL: www.hc-sc.gc.ca

    Language: English - Date: 2013-07-12 14:25:49
    308Research / Clinical Data Management / Medical informatics / Pharmaceuticals policy / Drug safety / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / MedDRA / Electronic Common Technical Document / La Hulpe / Medicine / Clinical research / Health

    18 July[removed]MEETING REPORT ICH Steering Committee June 5-6, 2013, La Hulpe, Brussels, Belgium

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    Source URL: www.ich.org

    Language: English - Date: 2013-10-14 04:55:44
    309Research / Technology / Pharmaceutical industry / Medical informatics / Electronic Common Technical Document / Common Technical Document / Global Harmonization Task Force / Drug Master File / Clinical trial / Medicine / Clinical research / Clinical Data Management

    Microsoft Word - ctd_prep_rev_nds-eng.doc

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    Source URL: www.hc-sc.gc.ca

    Language: English - Date: 2014-06-17 11:30:03
    310Electronic Common Technical Document / Markup languages / Technical communication / Document Type Definition / Checksum / Hyperlink / HTML element / Error message / Bookmark / Computing / Clinical Data Management / Clinical research

    Microsoft Word - notice_avis revised_ectd_validation_rules v0.2a eng.docx

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    Source URL: www.hc-sc.gc.ca

    Language: English - Date: 2013-06-24 11:53:04
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