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Paediatric-use marketing authorisation
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#	Item
1	There are major practical and ethical issues in relation to studying medicines in children, A new Paediatric Regulation entered into force in early Add to Reading List Source URL: tinn2-project.org Language: English - Date: 2011-02-25 05:09:54 Health Medicine European Medicines Agency Azithromycin Paediatric-use marketing authorisation Clinical trial Adverse effect Safety monitoring EudraCT Pharmaceutical industry Clinical research Research
2	Microsoft Word - ViroPharma SPRL Paediatric Regulation 26 November 2012.docx Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:41 Clinical research Pharmaceutical industry European Medicines Agency Paediatric-use marketing authorisation Supplementary protection certificate ViroPharma Orphan drug Midazolam Summary of Product Characteristics Pharmaceutical sciences Pharmacology Health
3	Microsoft Word - Parents organizations answer to Public Consultation .doc Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:09 European Medicines Agency Pharmaceutical industry Supplementary protection certificate Paediatric-use marketing authorisation EudraCT Food and Drug Administration Research Clinical research Pharmaceutical sciences
4	‘EXPERIENCE ACQUIRED’ AND ‘LESSONS LEARNT’ SUBMITTED FOR PUBLIC CONSULTATION Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:40 Clinical research European Medicines Agency Pharmaceutical industry Supplementary protection certificate Paediatric-use marketing authorisation Pharmacovigilance Paediatric radiology Pharmaceutical sciences Health Pharmacology
5	Microsoft Word - ITCC_5 year SURVEY_Comments_2012_11_28.docx Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:24 Clinical research European Medicines Agency Pharmaceutical industry Supplementary protection certificate Paediatric-use marketing authorisation Food and Drug Administration Regulatory requirement Pharmaceutical sciences Health Pharmacology
6	EUROPEAN GENERIC MEDICINES ASSOCIATION POSITION PAPER EGA CONTRIBUTION TO EC PUBLIC CONSULTATION ON “GENERAL REPORT ON EXPERIENCE ACQUIRED AS A RESULT OF THE Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:33 Law Pharmacology Clinical research Intellectual property law Supplementary protection certificate European Medicines Agency Paediatric-use marketing authorisation Generic drug Chemical patent Pharmaceutical industry Pharmaceutical sciences Patent law
7	GRIP_Comments_PaedReg_consultation_26[removed] Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:42 Health Pharmaceutical industry European Medicines Agency Supplementary protection certificate Paediatric-use marketing authorisation Orphan drug EudraCT Pharmaceutical sciences Clinical research Research
8	Microsoft Word - FINAL_En_201211_ Prescrire_ReglementPedia_ReponseConsult Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:24 Pharmacology Pharmaceutical industry Pharmaceuticals policy European Medicines Agency Paediatric-use marketing authorisation Supplementary protection certificate Midazolam Food and Drug Administration Clinical Trials Directive Pharmaceutical sciences Clinical research Research
9	Ref. Ares[removed][removed]EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products – authorisations, EMA Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:00 Health Research Pharmaceutical industry European Medicines Agency Supplementary protection certificate Paediatric-use marketing authorisation Pharmacovigilance Summary of Product Characteristics Pharmaceutical sciences Pharmacology Clinical research
10	Better Medicines for Children Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:12:28 Pharmacology European Medicines Agency Supplementary protection certificate EudraLex EudraCT Paediatric-use marketing authorisation Clinical research Research Pharmaceutical sciences