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Electronic common technical document
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291	Microsoft Word - Final ICH SC Summary Brussels 2007_with links.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-21 10:46:45 Research Medicine Health MedDRA Electronic Common Technical Document Environmental Working Group Quality by Design International Organization for Standardization ISO 10303 Pharmacology Clinical research Pharmaceuticals policy
292	ICH STEERING COMMITTEE November 6-11, 2010 Fukuoka, Japan SUMMARY 1. Opening Discussions The ICH Steering Committee (SC) meeting in Fukuoka was chaired by MHLW. The Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-21 10:46:14 Medicine Research Drug safety Medical informatics Pharmaceuticals policy Electronic Common Technical Document MedDRA Environmental Working Group Fukuoka Health Clinical research Pharmacology
293	Microsoft Word - ICH SC Meeting Tallinn 2010.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-21 10:46:46 Pharmaceuticals policy MedDRA Medicine Drug safety Electronic Common Technical Document Environmental Working Group Health International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Research Pharmacology
294	An Overview of the Draft Guidance ANDA Submissions—Refuseto-Receive Standards Johnny Young, M.A.L.A. Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Clinical Data Management Electronic Common Technical Document Competitions Digital media Abbreviated New Drug Application Food and Drug Administration Electronic submission Bioequivalence Clinical research Research Pharmaceutical sciences
295	DRUG MASTER FILES UNDER GDUFA: DMF Basics Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Health Clinical research Drug Master File Drug safety New Drug Application Electronic Common Technical Document Generic drug Food and Drug Administration Pharmaceutical industry Pharmaceuticals policy
296	Overview: Draft Guidance for Industry ANDA Submissions - Content and Format of Abbreviated New Drug Applications Elizabeth Giaquinto, JD Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Drug safety Medical informatics Abbreviated New Drug Application Electronic Common Technical Document New Drug Application Common Technical Document Food and Drug Administration Research Pharmaceutical sciences Pharmaceutical industry
297	A Filing Reviewer’s Perspective on Electronically Submitted Documents Add to Reading List Source URL: www.fda.gov Language: English Food law Research Competitions Digital media Electronic Common Technical Document Electronic submission Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Filing Medicine Health Food and Drug Administration
298	Optimizing your eCTD ANDA Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical Data Management Medical informatics Drug safety Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Abbreviated New Drug Application Food and Drug Administration Clinical research Research Medicine
299	Johnny Young Office of Generic Drugs/Division of Labeling and Program Support An Overview of the Draft Guidance for Industry ANDA Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Clinical Data Management Electronic Common Technical Document Competitions Digital media Abbreviated New Drug Application Food and Drug Administration Electronic submission Regulated Product Submissions Research Clinical research Medicine
300	Notice - Draft Canadian Module 1 Schema Version 2.1 Add to Reading List Source URL: www.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

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