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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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241	Microsoft Word - 9849fnl[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Science Clinical research Pharmacology Quality by Design Validity Validation Regulatory requirement International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Quality Pharmaceuticals policy Pharmaceutical industry
242	Final Concept Paper ICH E2B(R3) IWG Electronic Transmission of Individual Case Safety Reports Dated 25 June 2013 Endorsed by the Steering Committee: 10 July 2013 Add to Reading List Source URL: www.ich.org Language: English - Date: 2013-07-19 12:06:32 Clinical research Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmaceuticals policy International standards Medical informatics XML Health Level 7 R3 Computing Health Medicine
243	Microsoft Word - E2C_R2_ Final Concept Paper December 2010.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:14:17 Safety Pharmaceutical sciences Pharmacology Actuarial science Security International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacovigilance Environmental Working Group Clinical trial Clinical research Management Drug safety
244	Microsoft Word - E2C_R2_ IWG Concept Paper 15 November 2012.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2013-02-15 06:26:40 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Drug safety Pharmaceuticals policy
245	Microsoft PowerPoint - ICH_E2F_step_4_October 2010.ppt [Compatibility Mode] Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:14:00 Pharmaceutical sciences Pharmacology Health Drug safety Medical ethics Regulatory requirement International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Council for International Organizations of Medical Sciences Clinical trial Clinical research Research Pharmaceuticals policy
246	Microsoft Word - Concept paper & Business plan.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-21 12:41:02 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Research Pharmaceutical industry Clinical research Pharmaceuticals policy Drug safety
247	Microsoft Word - E2C_R2_ Final Business Plan December 2010.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:14:11 Drug safety Pharmacology Clinical research Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacovigilance Food and Drug Administration Medical guideline Environmental Working Group Medicine Health Pharmaceutical sciences
248	November[removed]ICH Procedures Version 1.1 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-03-13 04:57:18 Pharmaceutical sciences Pharmaceutics Clinical Data Management Pharmaceuticals policy Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use MedDRA Standard operating procedure Electronic Common Technical Document Clinical research Research Pharmaceutical industry
249	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:13:28 Clinical research Medicine Pharmaceuticals policy Drug safety Pharmaceutical industry Pharmacovigilance Adverse effect Regulatory requirement Adverse event Pharmacology Pharmaceutical sciences Health
250	Electronic Transmission of Individual Case Safety Reports Message Specification Document Version 2.3 November 9, 2000 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICAL Add to Reading List Source URL: www.fda.gov Language: English Technology Information Standard Generalized Markup Language International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use HTML Document Type Definition Health Level 7 Electronic data interchange CALS Computing Markup languages Technical communication