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Harmonisation
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981	Microsoft Word - 10317dft[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Research Clinical research Drug safety Pharmaceuticals policy Food and Drug Administration Regulatory requirement Pharmacovigilance International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Pharmaceutical sciences Health Pharmacology
982	Guidance for Industry M4: The CTD - Efficacy Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Drug safety Clinical Data Management Pharmaceutical industry Common Technical Document Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Food and Drug Administration Pharmacovigilance Clinical research Research Pharmaceutical sciences
983	Microsoft Word - 8411fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Clinical research Pharmacopoeias Pharmaceuticals policy Center for Biologics Evaluation and Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Biologic Center for Drug Evaluation and Research Medicine Food and Drug Administration Health
984	Microsoft Word - 9392fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Pharmaceuticals policy Drug safety Therapeutics Center for Biologics Evaluation and Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacopoeia Medicine Health Pharmaceutical sciences
985	Federal Register / Vol. 64, No[removed]Friday, June 25, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D–0444] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Drug discovery Clinical research Pharmaceuticals policy Regulatory requirement International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Food and Drug Administration Drug development Pre-clinical development Pharmaceutical sciences Pharmacology Research
986	Guidance for Industry M4Q: The CTD-Quality August 2001 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Medical informatics Common Technical Document Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Validation Package insert Clinical research Research Pharmaceutical sciences
987	Guidance for Industry M4: Organization of the CTD U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Pharmacology Common Technical Document Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document Clinical trial Food and Drug Administration Research Clinical research Pharmaceutical sciences
988	GUIDELINE FOR GOOD CLINICAL PRACTICE Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:22 Science Electronic Common Technical Document Common Technical Document Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial HTML element Documentation Clinical research Research Clinical Data Management
989	Scientific Steering Committee The Second Report on Harmonisation Of Risk Assessment Procedures Appendix 6 APPENDIX 6 Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2012-03-20 14:33:49 Risk management Hazard analysis Actuarial science Emergency management Risk assessment Exposure assessment Hazard Biodiversity Pesticide Risk Management Ethics
990	Scientific Steering Committee The Second Report on Harmonisation of Risk Assessment Procedures APPENDIX 2 GLOSSARY OF TERMS Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2012-03-20 14:33:49 Medicine Pharmacology Risk management Hazard analysis Environmental health Risk assessment Exposure assessment Dose-response relationship No observable adverse effect level Toxicology Risk Health