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Global Harmonization Task Force
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#	Item
491	Responsible Office/Division Title: Regulatory Authority Council (RAC) Appointment Document No.: Pages: 1 of 3 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceuticals policy Pharmaceutical industry Pharmacology Global Harmonization Task Force Food and Drug Administration Good manufacturing practice Medical device Regulatory agency Medicine Health Medical equipment
492	The success of a well-managed post-market surveillance program relies on working with various stakeholders, both internal and external. Internal stakeholders of the Marketed Health Products Directorate (MHPD) include oth Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 16:55:14 Pharmacology Patient safety Clinical research Medical terms Health Products and Food Branch Postmarketing surveillance Marketed health products directorate Adverse effect Global Harmonization Task Force Medicine Health Health in Canada
493	Table of Contents Executive summary ............................................................................................................................ 1 Assessments of individual regulatory areas ............ Add to Reading List Source URL: www.albertacanada.com Language: English - Date: 2014-09-10 12:06:35 Global Harmonization Task Force Medical equipment
494	Notice: Adoption of Global Harmonization Task Force (GHTF) Guidance: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-10-02 10:21:51 Quality management Medical technology Quality Global Harmonization Task Force Pharmaceutical industry Medical device ISO Quality management system Verification and validation Technology Medicine Medical equipment
495	Our Mandate: To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biolo Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 17:13:26 Medical technology Medical equipment Medical device Global Harmonization Task Force Food and Drug Administration ISO 13485 ISO 14971 Quality management system Health Canada Medicine Technology Health
496	Health Product Vigilance Framework Release Date: [removed] Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:41 Pharmacology Medical equipment Medical technology Drug safety Pharmacovigilance Global Harmonization Task Force Canadian Institute for Health Information Patient safety European Medicines Agency Medicine Health Clinical research
497	November 28, 2011 Margaret A. Hamburg, MD FDA Commissioner Food and Drug Administration (FDA) Dockets Management Branch (HFA[removed]Fishers Lane, Room 1061 Add to Reading List Source URL: www.aaos.org Language: English - Date: 2013-07-18 14:02:58 Food and Drug Administration American Academy of Orthopaedic Surgeons Medical device Global Harmonization Task Force Medicine Health Medical equipment
498	Understanding Japanese Medical Device Requirements Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2012-06-18 00:45:42 Technology Medical equipment Pharmaceutical industry Pharmacology Medical technology Medical device Food and Drug Administration Marketing authorization Global Harmonization Task Force Medicine Health Pharmaceuticals policy
499	Prospective Registry Objectives Add to Reading List Source URL: www.fda.gov Language: English Medical equipment Clinical research Therapeutics United States Public Health Service Epidemiology Premarket approval Adverse event Center for Devices and Radiological Health Global Harmonization Task Force Health Medicine Food and Drug Administration
500	GUIDANCE DOCUMENT Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-09 17:21:33 Pharmaceutical industry Validity Medical technology Quality management Medical device Global Harmonization Task Force Verification and validation Validation Quality management system Medicine Technology Medical equipment

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