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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Results: 311

#	Item
71	Role of MedDRA® in Healthcare MedDRA® trademark is owned by IFPMA on behalf of ICH Add to Reading List Source URL: www.meddra.org Language: English - Date: 2013-11-08 15:43:39 Pharmaceutical industry Research MedDRA Pharmaceuticals policy Drug safety IFPMA International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Japan Pharmaceutical Manufacturers Association Pharmaceutical Research and Manufacturers of America Pharmaceutical sciences Pharmacology Clinical research
72	Role of MedDRA® in Global Medical Product Safety Harmonizing Terminology Across Nations and Languages MedDRA® trademark is owned by IFPMA on behalf of ICH Add to Reading List Source URL: www.meddra.org Language: English - Date: 2014-10-31 08:47:24 Clinical research Pharmaceutical industry MedDRA Pharmaceuticals policy Drug safety IFPMA International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Japan Pharmaceutical Manufacturers Association Pharmaceutical Research and Manufacturers of America Pharmaceutical sciences Pharmacology Medicine
73	16 September[removed]MEETING REPORT ICH Steering Committee 4 – 5 June 2014, Minneapolis, MN, USA Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-09-16 12:20:13 Clinical Data Management Health Drug safety Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document MedDRA Environmental Working Group Clinical trial Clinical research Research Pharmacology
74	986 W H O Te c h n i c a l Add to Reading List Source URL: www.wsmi.org Language: English - Date: 2014-07-04 08:07:12 Pharmacology Health Clinical research Pharmacy European Directorate for the Quality of Medicines The International Pharmacopoeia Pharmacopoeia Validation International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmaceutical sciences Pharmaceuticals policy Pharmaceutical industry
75	asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 79, No[removed]Wednesday, September 24, [removed]Notices with premarket review regulations and performance standards under sections 514 and 515 of the FD Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-10-07 13:23:43 Pharmacology Pharmaceuticals policy Food and Drug Administration Food law Pharmaceutical industry Bioequivalence Abbreviated New Drug Application International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Federal Food Drug and Cosmetic Act Medicine Clinical research Pharmaceutical sciences
76	16 September[removed]MEETING REPORT ICH Steering Committee 4 – 5 June 2014, Minneapolis, MN, USA Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-09-17 03:26:13 Clinical Data Management Health Drug safety Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document MedDRA Environmental Working Group Clinical trial Clinical research Research Pharmacology
77	Final Concept Paper M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH M4E(R1) Guideline dated 10 February 2014 Endorsed by the ICH Steering Committee on 5 June 2014 Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-10-10 07:42:02 Risk management Clinical research Pharmaceuticals policy Drug safety Medical informatics International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Medical guideline Food and Drug Administration Medicine Risk Health
78	Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Drug safety Pharmaceutical industry Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Food and Drug Administration Adverse event Addendum Pharmacovigilance Pharmaceutical sciences Clinical research Research
79	Federal Register / Vol. 79, No[removed]Thursday, October 9, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2002–D–0268 (formerly Docket No. 2002D–0005)] Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-10-09 03:12:49 Health Drug safety Pharmaceuticals policy Clinical research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacovigilance Office of Regulatory Affairs National Center for Toxicological Research Regulatory requirement Pharmaceutical sciences Food and Drug Administration Pharmacology
80	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: estri.ich.org Language: English - Date: 2012-06-04 19:13:02 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 Uniform resource identifier Computing Markup languages Technical communication