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Electronic common technical document
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211	-- Bert spiker, PhD, MD SENIOR VICE PRESIDENT SClENl.lflC AND REQUIATORY AFFAIRS .* Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-11-15 00:43:10 Science Common Technical Document Pharmaceutical industry Evaluation methods Clinical trial Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Research Clinical Data Management
212	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-12 17:51:51 Pharmaceutical industry Science Food and Drug Administration Pharmacology Clinical Data Management Electronic Common Technical Document Clinical trial New Drug Application Title 21 CFR Part 11 Clinical research Research Pharmaceutical sciences
213	Notice: Release of Health Canada’s Revisions to“1.6 Electronic Review Documents” in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format. Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:53 Research Medical informatics Electronic documents Electronic Common Technical Document Digital media Common Technical Document Electronic submission Portable Document Format Submission management Clinical Data Management Clinical research Computing
214	RE: DavidW. Blois,Ph.D. SeniorVice President GlobalRegulatoryPolicy Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-01-21 18:50:57 Grants Research Pharmaceutical industry Clinical Data Management Electronic Common Technical Document Technology Merck & Co. Portable Document Format Electronic submission Computing Competitions Digital media
215	SOPP 8422: Processing of Trans-BLA Submissions Version #1 Effective Date: April 18, 2011 I. Purpose The purpose of this document is to provide guidance to Center for Biologics Evaluation and Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Pharmaceutical industry Medical informatics Electronic Common Technical Document Common Technical Document Title 21 CFR Part 11 Electronic submission Center for Biologics Evaluation and Research Food and Drug Administration Medicine Research
216	CarolineNutleyhew, PhD ASSlSTANI INTERNATIONAL “ICE PRESlDENT REGULATORY AFFAIRS Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-11-19 05:16:10 Pharmaceutical industry Pharmacology Pharmaceutical Research and Manufacturers of America Validation Food and Drug Administration Document Electronic Common Technical Document Common Technical Document Pharmaceutical sciences Clinical research Research
217	October 27,2003 ;i[removed]yj,” f-j-J 2kj Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-12 17:50:21 Research Electronic Common Technical Document Medicine Filing Investigational New Drug Clinical research Clinical Data Management Medical informatics
218	Alan Goldhammer, PhD Associate Vice President, US Regulatory Affairs Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-12 17:50:22 Clinical Data Management Science Food and Drug Administration Pharmaceutical industry Medical informatics Electronic Common Technical Document Common Technical Document Title 21 CFR Part 11 Guidance document Clinical research Computing Research
219	October 15,2003 Via fax and UPS Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Drug safety Health Pharmaceutical industry Clinical Data Management Electronic Common Technical Document Investigational New Drug New Drug Application Electronic submission Clinical research Research Medicine
220	Alan Goldhammer, PhD Associate Vice President, US Regulatory Affairs Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-12 17:50:21 Science Medical informatics Documents Electronic Common Technical Document Food and Drug Administration Common Technical Document Guidance document Clinical trial Electronic submission Clinical research Research Clinical Data Management

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