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Common Technical Document
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541	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
542	Microsoft Word - new revised withdrawn[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Food and Drug Administration Clinical research Pharmaceuticals policy Drug safety Center for Drug Evaluation and Research Good manufacturing practice Investigational New Drug Common Technical Document Pharmaceutical sciences Research Medicine
543	Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Clinical Data Management Drug safety Pharmaceutical industry Electronic Common Technical Document Investigational New Drug Common Technical Document Center for Biologics Evaluation and Research Medicine Food and Drug Administration Research
544	Enhancing operational excellence: 18 Nov[removed] CMDh meeting with Interested Parties[removed]) Add to Reading List Source URL: www.hma.eu Language: English - Date: 2013-12-02 10:12:23 Validity Quality Validation Electronic Common Technical Document Technology Electronic submission Marketing authorization Requirement Science Pharmaceutical industry Clinical research Research
545	Meeting with IP 18 November 2013 Proposals from industry Submissions • Harmonise national portals to shift to EU Add to Reading List Source URL: www.hma.eu Language: English - Date: 2013-12-02 10:12:25 Validity Quality Validation Digital media Electronic Common Technical Document Electronic submission Requirement Science Technology Clinical research Pharmaceutical industry Research
546	CMDh Meeting with IP - Minutes - November 2011 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2012-01-25 04:52:21 Pharmaceutical industry Validity Clinical Data Management Validation Electronic Common Technical Document Clinical research Research Quality
547	Update of the BPG for validation in DCP and MRP - Input from the public consultation - Further issues for discussion in CMDh Add to Reading List Source URL: www.hma.eu Language: English - Date: 2011-11-25 05:45:40 Clinical Data Management Validity Quality Validation Electronic Common Technical Document Clinical research Research Pharmaceutical industry
548	Electronic submissions RMS technical validation and the Roadmap Reported by: Karin Gröndahl at IP/CMDh meeting November 2013 RMS technical validation Add to Reading List Source URL: www.hma.eu Language: English - Date: 2013-12-02 10:12:26 Validity Quality Validation Clinical Data Management Electronic Common Technical Document Audio power Technology Science Clinical research Pharmaceutical industry Research
549	MINUTES CMDh meeting with representatives of Interested Parties 12th November[removed]:30- 19:00 EMA, Room 4A Chairperson: Peter Bachmann Title Add to Reading List Source URL: www.hma.eu Language: English - Date: 2013-01-30 11:50:44 Health Drug safety Pharmacology Pharmacy Medical ethics Electronic Common Technical Document Pharmacovigilance European Federation of Pharmaceutical Industries and Associations Informed consent Medicine Pharmaceutical sciences Clinical research
550	CMD(h) – Meeting with stakeholders on DCP/MRP and other process improvements Combined presentation of all industry associations (AESGP, EFPIA,EGA) Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-06-10 09:05:55 Validity Quality Validation Electronic Common Technical Document Science Clinical research Pharmaceutical industry Research

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