Pharmaceutical Management Agency

Results: 383



#Item
1Pharmaceutical industry / Medical research / Health care / Pharmacology / Validity / Clinical data management / Clinical research / Quality / Validation / Marketing authorization / European Medicines Agency

BPGAutomatic validationEMA-CMDv

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Source URL: www.hma.eu

Language: English - Date: 2016-07-27 07:09:22
2Pharmaceuticals policy / Health / Medical research / Clinical data management / Clinical research / Pharmaceutical industry / European Union / EudraLex / European Medicines Agency / Electronic common technical document / Common Technical Document / Marketing authorization

1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:40
3Medical research / Clinical data management / Clinical research / Health / Pharmaceutical industry / Health informatics / Electronic common technical document / Pharmaceuticals policy / Marketing authorization / Committee for Medicinal Products for Human Use / Validation

PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union Presenters of the Day, from EMA

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:50
4Medical research / Health / Clinical data management / Clinical research / Electronic common technical document / Pharmaceutical industry / Agencies of the European Union / European Medicines Agency / Form / Marketing authorization / Email

Q & A for EMA eSubmission Gateway

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:47
5Pharmaceutical industry / Clinical data management / Health informatics / Agencies of the European Union / Clinical research / Electronic common technical document / European Medicines Agency / Marketing authorization / ASMF / EMA

Annex1 - A guide to the filenaming convention for eSubmission

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:00
6Clinical 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

Revision version 1.5 for public consultation Comments byJune 2016

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:57
7Pharmaceutical industry / Pharmaceuticals policy / European Union / Clinical data management / European Medicines Agency / Marketing authorization / Closure / Validation

Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use Doc. Ref: CMDhFebruary 2016

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Source URL: www.hma.eu

Language: English - Date: 2016-02-19 11:51:17
8Clinical research / Clinical data management / Pharmaceutical industry / Electronic common technical document / Pharmaceuticals policy / Marketing authorization / Probability distribution / Validation

European Medicines Agency  Evaluation of Medicines for Human Use  London, August 2009  EMEA  V1.0 

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:52
9Clinical research / Pharmaceutical industry / Clinical data management / Drug safety / Electronic common technical document / Supplementary protection certificate / European Medicines Agency / Summary of Product Characteristics / Pharmacovigilance / Validation / Drug Master File

DOC Document

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Source URL: www.ema.europa.eu

Language: English - Date: 2016-07-20 07:22:57
10Clinical 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

RTF Document

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:41
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