Electronic common technical document

Results: 446



#Item
241Health informatics / International standards / Multi-agent systems / Standards organizations / Health Level 7 / Computing / Electronic Common Technical Document / Medical informatics / Health / Medicine

ICH M8 EWG/IWG Work Plan 18 June 2014 Topic Adopted: 11 November 2010 Last Face-to-Face Meeting: Minneapolis, June 2014

Add to Reading List

Source URL: www.ich.org

Language: English
242Clinical research / Pharmaceutical industry / Drug discovery / Clinical Data Management / Medical research / Biomarker / Electronic Common Technical Document / Proteomics / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Medicine / Biology / Research

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE BIOMARKERS RELATED TO DRUG OR

Add to Reading List

Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:13:54
243Medicine / Medical informatics / Electronic Common Technical Document / Food and Drug Administration / Pharmaceutical industry / Common Technical Document / Health Canada / Clinical trial / Electronic submission / Clinical research / Research / Clinical Data Management

E2F: Development Safety Update Report (DSUR)

Add to Reading List

Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-06-24 11:53:03
244Medical informatics / Health / Research / Drug safety / Electronic Common Technical Document / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Common Technical Document / Health Level 7 / Clinical research / Medicine / Clinical Data Management

Microsoft Word - M8 eCTD Concept Paper.doc

Add to Reading List

Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:07:53
245Health Canada / Research / Electronic Common Technical Document / Health / Common Technical Document / Clinical Data Management / Health in Canada / Medicine

November 19, 2010 Our file number: [removed]Notice Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot at Health Canada, including the adoption of International C

Add to Reading List

Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-06-24 11:52:35
246Reference / Computer graphics / Standards / Graphics file formats / ISO standards / Electronic Common Technical Document / Portable Document Format / Document management system / Document file format / Computing / Computer file formats / Adobe Systems

Microsoft Word - iso032000-final-5apr11.docx

Add to Reading List

Source URL: estri.ich.org

Language: English - Date: 2014-06-23 03:28:54
247Clinical research / Pharmacy / Pharmaceuticals policy / Pharmaceutical industry / Pharmacovigilance / European Medicines Agency / Electronic Common Technical Document / Drug discovery / Food and Drug Administration / Pharmaceutical sciences / Pharmacology / Health

Microsoft Word - HPK-英語版PMDA Updates12月号(最終版).docx

Add to Reading List

Source URL: www.pmda.go.jp

Language: English - Date: 2013-12-20 05:50:25
248Clinical research / Pharmaceutical industry / Pharmacy / Pharmaceuticals policy / Pharmacovigilance / Electronic Common Technical Document / Drug discovery / Clinical trial / Food and Drug Administration / Pharmaceutical sciences / Pharmacology / Medicine

Microsoft Word - 英語版PMDA Updates6月号(確定).docx

Add to Reading List

Source URL: www.pmda.go.jp

Language: English - Date: 2013-06-26 20:54:52
249Business / Electronic Common Technical Document / Technology / Research / Corrective and preventive action / Computer file / Clinical Data Management / Clinical research / Medical informatics

Specifications for eCTD Validation Criteria v2.2

Add to Reading List

Source URL: www.fda.gov

Language: English
250Food and Drug Administration / Clinical Data Management / Electronic Common Technical Document / Email / Center for Biologics Evaluation and Research / Medicine / Clinical research / Research

Microsoft Word - r_50A_Information Request[removed]June 2010.doc

Add to Reading List

Source URL: www.fda.gov

Language: English
UPDATE