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European Medicines Agency
Results: 2389

#	Item
51	EMEA/CMDvCMDv/GUI/006 GUIDANCE for Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-03 09:58:44 Pharmaceutical industry Technical communication Summary of Product Characteristics Documentation Drug safety Chemical safety European Medicines Agency
52	Revision version 1.5 for public consultation Comments byJune 2016 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:57 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Common Technical Document Marketing authorization ASMF European Medicines Agency European Directorate for the Quality of Medicines Dossier Electronic submission
53	CMDh meeting with IPs on MRP_DCP Improvements - Minutes -May 2016 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-08-02 09:25:15 Agencies of the European Union European Medicines Agency European Union European Federation of Pharmaceutical Industries and Associations Rup
54	EU CTR Frequently Asked Questions Add to Reading List Source URL: www.clinicaltrialsregister.eu Language: English - Date: 2016-07-13 04:51:15 Clinical research Pharmaceuticals policy Clinical trials Design of experiments Pharmaceutical industry EudraCT Clinical trials registry European Medicines Agency Clinical Trials Directive Pharmacovigilance EudraPharm Phases of clinical research
55	CR Acceptable Usage Policy Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:46 Clinical data management Clinical research Electronic common technical document Pharmaceuticals policy Agencies of the European Union European Medicines Agency EUDRANET Common Technical Document Application programming interface Repository
56	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
57	280 The Protection of Proprietary Data in Novel Foods EFFL Add to Reading List Source URL: www.lexxion.de Language: English - Date: 2016-02-20 17:50:01 European Union law Pharmaceuticals policy Test data exclusivity European Medicines Agency Novel food Patent claim Data Protection Act Good laboratory practice
58	EU Clinical Trials Register Disclaimer: The explanations are provided for the benefit of public users of the system and to enhance general understanding of terms used. They are not intended as the regulatory definitions Add to Reading List Source URL: www.clinicaltrialsregister.eu Language: English - Date: 2016-07-13 04:51:15 Clinical research Pharmaceuticals policy Drug discovery Clinical trials Drug safety Pharmacovigilance European Medicines Agency EudraCT Clinical Trials Directive Gene therapy Clinical EudraVigilance
59	AESGP AmsterdamFebruaryConference report Add to Reading List Source URL: www.aesgp.eu Language: English Pharmaceuticals policy Agencies of the European Union Clinical pharmacology Drugs Drug safety European Medicines Agency Heads of Medicines Agencies Pharmacovigilance Prescription drug Adverse effect European Federation of Pharmaceutical Industries and Associations Pharmaceutical drug
60	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