Electronic common technical document

Results: 446



#Item
421Validity / Quality / Validation / Electronic Common Technical Document / Science / Clinical research / Pharmaceutical industry / Research

CMD(h) – Meeting with stakeholders on DCP/MRP and other process improvements Combined presentation of all industry associations (AESGP, EFPIA,EGA)

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Source URL: www.hma.eu

Language: English - Date: 2014-06-10 09:05:55
422Electronic Common Technical Document / Clinical research / Research / Clinical Data Management

Stakeholders’ Information 55th Heads of Medicines Agencies Meeting Hilton Arc De Triomphe Paris Hotel 6-7 November 2008 HMA – HUMAN Meeting The Heads of Medicines Agencies for human medicinal products met on 6 Novemb

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Source URL: www.hma.eu

Language: English - Date: 2008-11-13 12:51:21
423Medicine / Clinical research / Drug safety / Pharmacovigilance / Pharmacy / MedDRA / Pharmaceutical industry / Electronic Common Technical Document / Biosimilar / Pharmacology / Pharmaceutical sciences / Research

Draft Report: IPRF 11 – 12 November 2013 Date: 22 November 2013 Draft Report International Pharmaceuticals Regulators Forum Meeting in Osaka, Japan; 11-12 November 2013

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Source URL: ec.europa.eu

Language: English - Date: 2014-05-05 07:48:07
424Clinical research / Pharmaceuticals policy / Medical informatics / Clinical Data Management / Clinical Data Interchange Standards Consortium / Prescription Drug User Fee Act / Abbreviated New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Electronic Common Technical Document / Food and Drug Administration / Medicine / Health

FDASIA  and   Standardized  Electronic  Data:     Where  Are  We?   FDA/PhUSE  Computational  Science  Symposium   Mary  Ann  Slack,  FDA/CDER     March  18,  2

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Source URL: www.phusewiki.org

Language: English - Date: 2013-05-29 09:36:05
425Research / Clinical Data Management / Minutes / Agenda / Electronic Common Technical Document / Meetings / Parliamentary procedure / Clinical research

[removed]April 2014 EMA/CMDh[removed]COORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES - HUMAN MEETING

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:55:48
426Medical informatics / Electronic Common Technical Document / Technology / Computing / Pharmaceutical industry / Common Technical Document / Electronic submission / Validation / Email / Clinical Data Management / Clinical research / Research

Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDh[removed]Rev2 April[removed]How to deal with National Translations of the Product Information Question 1.1

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:20:47
427Medical informatics / Electronic Common Technical Document / Computing / Technology / Pharmaceutical industry / Common Technical Document / Electronic submission / Validation / Email / Clinical Data Management / Clinical research / Research

Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDh[removed]Rev1Rev2 July 2013 April[removed]How to deal with National Translations of the Product Information

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Source URL: www.hma.eu

Language: English - Date: 2014-05-06 10:20:48
428Pharmaceutics / Pharmaceutical sciences / European Medicines Agency / Electronic Common Technical Document / Committee for Medicinal Products for Human Use / Medicines and Healthcare products Regulatory Agency / EMA / Validation / Email / Clinical research / Pharmaceutical industry / Research

21 May 2014 EMA[removed]Rev. 8 Dossier requirements for Centrally Authorised Products (CAPs) Submission of applications to the European Medicines Agency, Members of the Committee for Medicinal Products for Human use

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Source URL: www.ema.europa.eu

Language: English - Date: 2014-05-27 12:01:43
429Pharmacist / Alternative medicine / Communication design / Logos / Pharmacy

CONCEPT PROPOSAL RESPONSE DOCUMENT FOR PUBLIC CONSULTATION ABOUT THE COMMON LOGOTYPE FOR LEGALLY ESTABLISHED ONLINE PHARMACIES IN THE EU CONSULTATION TOPICS 1. Technical, electronic and cryptographic requirements for the

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:40:11
430Research / Medical informatics / Electronic Common Technical Document / Markup languages / Technical communication / Regulated Product Submissions / Computing / Clinical Data Management / Clinical research

Guidance for Industry: ICH M2 eCTD: Electronic Common Technical Document Specification

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Source URL: www.medauthor.com

Language: English - Date: 2011-07-20 19:52:34
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