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#	Item
151	Q&A on QP declaration Meeting with IPs on DCP_MRP Improvements 16. November 2016 Inger Heggebø The Norwegian Medicines Agency Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-11-27 10:53:15 Pharmaceutical industry Pharmaceuticals policy Drug Master File QP Qualified person
152	CMDh-IP Meeting \| London\| 19 MayHarmonised implementation of risk minimisation measures in the context of the referral procedures Implementation of risk minimisation measures Add to Reading List Source URL: www.hma.eu - Date: 2015-05-29 10:18:51
153	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
154	Microsoft Word - CMD_v_ GUI-016 Diluents - EMEA-CMDved. 01 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:37 Diluent Solutions Solvents Polypropylene
155	CMDh meeting with IPs - 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
156	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
157	CMDh QUESTIONS & ANSWERS GENERIC APPLICATIONS Doc. Ref.: CMDh, Rev.1 AprilSUBMISSION OF A DESCRIPTION OF PHARMACOVIGILANCE SYSTEM AND EU RISK Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-05-16 05:10:10 Pharmaceuticals policy Pharmaceutical industry Clinical research Drug safety Healthcare quality Bioequivalence Summary of Product Characteristics Marketing authorization Test data exclusivity Pharmacovigilance Supplementary protection certificate European Medicines Agency
158	CMDh-IP Meeting \| London\| 19 MayQ&A on API-mixtures An unresolved regulatory problem What is the issue? Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-05-29 10:18:55 Agencies of the European Union European Medicines Agency European Union Asian Pacific Internet Exchange Association EMA
159	Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDhRev.23 JuneAprilHow to deal with National Translations of the Product Information Question 1.1 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-01 10:53:25 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Digital media Electronic submission Validation
160	CMDv GUI-22 Format & no. copies initial MAAEMA-CMDv Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-06-15 05:38:46 Electronic signage Signage Yes

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