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Marketing authorization
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#	Item
51	22 JulyJuly 2016 EMAv7.0 User Guidance for Marketing Authorisation Holders (MAHs) for PSUR Repository Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:02 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Marketing authorization Common Technical Document Validation Product lifecycle
52	Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use Doc. Ref: CMDhFebruary 2016 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-02-19 11:51:17 Pharmaceutical industry Pharmaceuticals policy European Union Clinical data management European Medicines Agency Marketing authorization Closure Validation
53	Rules on the Medicines Act Add to Reading List Source URL: oag.gov.bt Language: English - Date: 2015-04-15 23:30:42 Pharmaceutical industry Pharmaceuticals policy Food and Drug Administration Clinical trial Design of experiments Product testing Good laboratory practice Marketing authorization European Medicines Agency
54	Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:51 Clinical research Clinical data management Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Common Technical Document Marketing authorization Electronic submission Drug Master File
55	European Medicines Agency Evaluation of Medicines for Human Use London, August 2009 EMEA V1.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:52 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Marketing authorization Probability distribution Validation
56	BPGWorksharingEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-07-07 08:06:03 Pharmaceutical industry Agencies of the European Union Pharmaceuticals policy European Medicines Agency European Union Marketing authorization Summary of Product Characteristics
57	doi:094471103322331656 Add to Reading List Source URL: escop.com Language: English - Date: 2015-05-22 17:13:30 Pharmaceuticals policy Directive 2001/83/EC Marketing authorization European Directive on Traditional Herbal Medicinal Products Draft:European Scientific Cooperative on Phytotherapy
58	CMDh QUESTIONS & ANSWERS PHARMACOVIGILANCE LEGISLATION REGULATION (EU) NOAND DIRECTIVEEU Doc. Ref.: CMDh, Rev.14 OctoberJanuary 2016 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-04-20 04:52:35 Pharmaceuticals policy Drug safety Healthcare quality Clinical research Pharmacovigilance Marketing authorization Risk management plan
59	RTF Document Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:41 Clinical research Clinical data management Pharmaceutical industry Pharmaceuticals policy Electronic common technical document Common Technical Document Marketing authorization Validation Pharmacovigilance HTML element Summary of Product Characteristics European Medicines Agency
60	CMDv BPG-12 Informed consentEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:46 Pharmaceutical industry Pharmaceuticals policy Marketing authorization Informed consent Consent