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Electronic common technical document
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151	APPLICANT’S RESPONSE DOCUMENT IN MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES FOR MARKETING AUTHORISATION APPLICATIONS Doc. Ref.: CMDh[removed]Rev4 February 2012 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2012-03-08 05:45:57 Common Technical Document Clinical Data Management Clinical research Electronic Common Technical Document
152	[removed]November 2014 EMA/CMDh[removed]COORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES - HUMAN MEETING Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-11-26 05:36:03 Research Pharmaceutical industry Agenda Minutes Validation Electronic Common Technical Document European Directorate for the Quality of Medicines Business Meetings Clinical research Parliamentary procedure
153	Tokyo ICH Symposium: Hot Topics and influence on Asia Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-12-11 04:59:10 Research Pharmaceuticals policy Pharmaceutics Japan Pharmaceutical Manufacturers Association Pharmacology Pharmacy Electronic Common Technical Document Good Clinical Practice Environmental Working Group Clinical research Pharmaceutical sciences Pharmaceutical industry
154	Microsoft Word - ICH SC Meeting St. Louis 2009.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-11-11 11:03:12 Medicine Pharmacology Medical informatics Drug safety Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document MedDRA Environmental Working Group Clinical research Health Research
155	(System Info[removed]SMITH MICHAEL[removed]:48:05 SMITHM) RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food and Drug Administration Pharmaceutical industry Clinical Data Management Electronic Common Technical Document Validation Center for Biologics Evaluation and Research Biologic Vaccine Research Medicine Clinical research
156	Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Add to Reading List Source URL: www.fda.gov Language: English Center for Biologics Evaluation and Research Investigational New Drug Federal Food Drug and Cosmetic Act Abbreviated New Drug Application New Drug Application Medical device Electronic Common Technical Document Title 21 CFR Part 11 Structured Product Labeling Medicine Food and Drug Administration Health
157	Microsoft Word - ICH SC Meeting Tallinn 2010.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-11-11 11:03:12 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
158	ICH STEERING COMMITTEE November 9-10, 2011 Seville, Spain SUMMARY 1. Opening Discussions The ICH Steering Committee (SC) meeting in Seville was chaired by the EU. The Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-11-11 11:03:12 Drug safety Health Medicine Pharmacology Clinical Data Management Electronic Common Technical Document MedDRA Environmental Working Group EudraVigilance Clinical research Research Pharmaceuticals policy
159	16 September[removed]MEETING REPORT ICH Steering Committee 4 – 5 June 2014, Minneapolis, MN, USA Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-11-11 11:03:12 Clinical Data Management Health Drug safety Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document MedDRA Environmental Working Group Clinical trial Clinical research Research Pharmacology
160	Microsoft Word - ICH SC Meeting Yokohama Revised Summary clean.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-11-11 11:03:12 Research Medicine Medical informatics Pharmaceuticals policy Pharmaceutical industry Electronic Common Technical Document MedDRA Environmental Working Group Quality by Design Health Clinical research Pharmacology

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