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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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231	Microsoft PowerPoint - optimizing_your_ectd_anda-jared_lantzy-final.ppt [Read-Only] [Compatibility Mode] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical Data Management Medical informatics Drug safety Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Abbreviated New Drug Application Food and Drug Administration Clinical research Research Medicine
232	[removed]Federal Register / Vol. 69, No[removed]Friday, April 30, [removed]Notices Grants Management Office signs and issues the award notice. Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-04-30 09:00:58 Pharmaceuticals policy Pharmacology Pharmaceutical industry Food and Drug Administration Drug safety Regulatory requirement New Drug Application European Medicines Agency International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Pharmaceutical sciences Research
233	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER) Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-04-10 10:33:50 Pharmaceutical industry Pharmacology Drug safety Health Pharmaceuticals policy Regulatory requirement Pharmacovigilance Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Pharmaceutical sciences Research
234	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Addendum to E2C Guideline : Periodic Safety Update Reports for Marketed Drugs and Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:13:22 Health Medicine Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacovigilance Premenstrual syndrome Safety Council for International Organizations of Medical Sciences Vigilance Clinical research Pharmaceuticals policy Drug safety
235	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper E2F: Development Safety Update Report dated 7 September 2006 Endorsed by the ICH S Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:14:08 Health International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Environmental Working Group Serious adverse event Council for International Organizations of Medical Sciences Pharmacovigilance Adverse event Clinical research Research Pharmaceutical sciences
236	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper E2E: Pharmacovigilance Planning Dated and endorsed by the Steering Committee on 11 Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:13:29 Medicine Drug safety Pharmacy Clinical research Pharmaceuticals policy Pharmacovigilance International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmaceutical drug Pharmaceutical industry Pharmacology Pharmaceutical sciences Health
237	Overview of ICH Procedures November 2013 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 05:03:04 Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Health Pharmaceutical sciences Pharmaceutical industry Pharmacology Clinical research Research Pharmaceuticals policy
238	Microsoft Word - E3 Q&As_R1_ Step4.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-07-17 04:51:43 Scientific method Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Adverse event Common Technical Document Institutional review board Electronic Entertainment Expo Communications protocol Clinical research Research Science
239	E2C(R2) Implementation Working Group ICH E2C(R2) Guideline: Periodic Benefit-Risk Evaluation Report Questions & Answers Current version dated 31 March 2014 Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-04-11 06:15:12 Food and Drug Administration Health Medicine Pharmacology Pharmaceutical industry Investigational New Drug Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical research Drug safety Research
240	CTD General Q&As June[removed] Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:13:20 Pharmaceutical sciences Pharmacology Pharmaceutical industry Drug discovery Health Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Regulatory requirement Drug development Clinical research Pharmaceuticals policy Research