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Electronic common technical document
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201	DATE SUBMITTED TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR[removed]) Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Pharmacology Therapeutics United States Public Health Service Paperwork Reduction Act Electronic Common Technical Document Biologic License Application New Drug Application Food and Drug Administration Clinical research Research
202	Future Activity of ICH From the FDA Point of View Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Pharmacology Pharmaceutical industry Pharmaceuticals policy Good manufacturing practice Electronic Common Technical Document Food and Drug Administration Clinical trial Good Clinical Practice Pharmaceutical sciences Research Health
203	MEMBER STATES RECOMMENDATION ON THE COVER LETTER FOR NEW APPLICATIONS SUBMITTED THROUGH THE MRP/DCP Doc. Ref.: CMDh[removed]Rev3 March[removed]With every MA application, the applicant is required to provide a cover letter Add to Reading List Source URL: www.hma.eu Language: English - Date: 2012-03-27 09:26:07 Clinical Data Management Electronic Common Technical Document Recruitment Management Validation Electronic submission Human resource management Cover letter Clinical research Research Pharmaceutical industry
204	FDA Regional Technical Specifications for ICH E2B (R3) Implementation Postmarket Submission of Individual Case Safety Reports (ICSRs) for Vaccines Draft Technical Specifications Document This Document is incorporated by Add to Reading List Source URL: www.fda.gov Language: English Research Drug safety Medical informatics Clinical research Clinical Data Management Vaccine Adverse Event Reporting System Structured Product Labeling Electronic Common Technical Document Adverse Event Reporting System Medicine Food and Drug Administration Health
205	Microsoft PowerPoint - eCTD by the Numbers.ppt Add to Reading List Source URL: www.fda.gov Language: English Clinical research Drug safety Food and Drug Administration Pharmaceutical industry Pharmacology Electronic Common Technical Document Investigational New Drug New Drug Application Drug Information Association Pharmaceutical sciences Research Medicine
206	MEMBER STATES RECOMMENDATION ON THE COVER LETTER FOR NEW APPLICATIONS SUBMITTED THROUGH THE MRP/DCP Doc. Ref.: CMDh[removed]Rev2 April 2008Rev3 March 2012 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2012-03-27 09:26:08 Pharmaceutical industry Electronic Common Technical Document Grants Electronic submission Validation Science Medicine Clinical research Research Clinical Data Management
207	Microsoft PowerPoint[removed]Ventura.ppt Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Medicine Electronic Common Technical Document Pharmaceutical industry Drug safety Food and Drug Administration Validation Bookmark Investigational New Drug Clinical research Research Clinical Data Management
208	Computational Science and Data Standards in CDER ` Chuck Cooper, M.D. Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Food and Drug Administration Clinical Data Management Medical informatics Clinical Data Interchange Standards Consortium Microsoft PowerPoint Center for Drug Evaluation and Research Electronic Common Technical Document Pharmaceutical sciences Research Medicine
209	Ensuring a Successful Submission Connie Robinson-Kuiperi, RAC, PMP Office of Business Process Support Center for Drug Evaluation and Research November 5, 2008 Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Competitions Digital media Research Electronic Common Technical Document Science Electronic submission Graphical user interface Portable Document Format Computing Clinical Data Management Clinical research
210	Guidance for Industry Providing Regulatory Submissions in Electronic Format Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Health Drug safety Clinical Data Management Pharmaceutical industry Electronic Common Technical Document Investigational New Drug Common Technical Document Title 21 CFR Part 11 Medicine Research Clinical research

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