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Electronic common technical document
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#	Item
221	The Evolution of ICH Shift From Input to Output-The Influence of the CTD Justina A. Molzon, MS Pharm, JD Associate Director for International Programs Center for Drug Evaluation and Research US Food and Drug Administrati Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 04:06:30 Clinical research Clinical Data Management Pharmaceutical industry Electronic Common Technical Document MedDRA IFPMA Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Common Technical Document Pharmaceutical sciences Research Pharmacology
222	Alan Goldhammer, PhD Associate Vice President, US Regulatory Affatrs Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-01-21 18:50:56 Clinical research Food and Drug Administration Pharmaceutical industry Clinical Data Management Medical informatics Electronic Common Technical Document Title 21 CFR Part 11 Portable Document Format Clinical trial Research Computing Medicine
223	EUROPEAN FEDERATION PHARMACEUTICAL Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:23:23 Pharmaceutical industry Science Food and Drug Administration Pharmacology Quality Electronic Common Technical Document Specification Title 21 CFR Part 11 European Federation of Pharmaceutical Industries and Associations Clinical research Pharmaceutical sciences Research
224	Ébauche de la ligne directrice - Préparation des activités réglementaires des drogues en format Electronic Common Technical Document Add to Reading List Source URL: hc-sc.gc.ca Language: French - Date: 2013-07-09 17:16:49
225	Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:48 Technology 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
226	ICH M4: Common Technical Document Modules IIA, IIB Nonclinical; Module III, Quality; Modules IV, Nonclinical; Module V, Efficacy Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical Data Management Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Nonclinical studies Clinical trial Executive summary Electronic Common Technical Document Clinical research Research Drug discovery
227	Draft Guidance Document - Creation of the Canadian Module 1 Backbone Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:45 Medical informatics Research Medicine Electronic Common Technical Document Drug safety Markup languages Common Technical Document Regulated Product Submissions XML Clinical Data Management Computing Clinical research
228	Notice - Draft Canadian Module 1 Schema Version 2.1 Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:49 Clinical research Medical informatics Electronic Common Technical Document Common Technical Document Health Canada XML Schema Health Products and Food Branch XML Computing Clinical Data Management Research
229	Guidance Document Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs) Published by authority of the Minister of Health Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-07-02 12:31:12 Pharmaceutical sciences Pharmaceutical industry Pharmaceuticals policy Drug safety Food and Drug Administration Clinical trial Regulatory requirement Electronic Common Technical Document Good manufacturing practice Clinical research Research Health
230	Microsoft Word - ectd_schema_ext_pro-eng.docx Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:53:04 Computing Clinical research Electronic Common Technical Document Health Canada Common Technical Document Clinical Data Management Research Medicine

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