{"product_id":"regulation-of-medical-products-isbn-9780727917805","title":"Regulation of Medical Products","description":"A concise but comprehensive text explaining the processes involved in regulation of drugs with particular emphasis on EU, USA and Australia.  Contributors. \u003cp\u003ePreface.\u003c\/p\u003e \u003cp\u003eAcknowledgements.\u003c\/p\u003e \u003cp\u003eThe Editors.\u003c\/p\u003e \u003cp\u003eHistory of drug regulation in the UK.\u003c\/p\u003e \u003cp\u003eRegulation of human medicinal products in the European Union.\u003c\/p\u003e \u003cp\u003eEuropean regulation of medical devices.\u003c\/p\u003e \u003cp\u003eThe supply of unlicensed medicines for particular patient use.\u003c\/p\u003e \u003cp\u003eControls on NHS medicines prescribing and expenditure in the UK (a historical perspective).\u003c\/p\u003e \u003cp\u003eThe regulation of therapeutic products in Australia.\u003c\/p\u003e \u003cp\u003eRegulatory and clinical trial systems in Japan.\u003c\/p\u003e \u003cp\u003eThe regulation of drug products by the United States Food and Drug Administration.\u003c\/p\u003e \u003cp\u003eThe US FDA in the drug development, evaluation, and approval process.\u003c\/p\u003e \u003cp\u003eTechnical requirements for registration of pharmaceuticals for human use: the ICH process and the Common Technical Document.\u003c\/p\u003e \u003cp\u003eAppendix: European guidelines relevant for pharmaceutical physicians.\u003c\/p\u003e \u003cp\u003eIndex\u003c\/p\u003e  \u003cp\u003e\u003cstrong\u003eJohn Griffin\u003c\/strong\u003e is the editor of \u003cem\u003eRegulation of Medical Products\u003c\/em\u003e, published by Wiley. \u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eJohn O'Grady\u003c\/strong\u003e is the editor of \u003cem\u003eRegulation of Medical Products\u003c\/em\u003e, published by Wiley.   \u003ci\u003e\u003cb\u003eThe Regulation of Medical Products\u003c\/b\u003e\u003c\/i\u003e is an essential reference book for pharmaceutical physicians and people in the field of the regulation of medicines, and will be of particular value to pharmaceutical physicians in higher medical training. Chapters are written by worldwide leading authorities on regulatory affairs, and explain the processes and regulations in the major drug producing countries. Contents include:\u003cbr\u003e \u003c\/p\u003e\u003cp\u003ehistory of drug regulation; regulation of human medicinal products in the European Union; European regulation of medicinal devices; the supply of unlicensed medicines for particular patient use; controls on NHS medicines; prescribing and expenditure in the UK; the regulation of drug products by the United States FDA; the US FDA in the drug development evaluation and approval process; technical requirements for registration of pharmaceuticals for human use; the ICH process and the common technical document.\u003cbr\u003e \u003c\/p\u003e \u003cp\u003eThis comprehensive and timely text will be an invaluable handbook for anyone prescribing, producing or working with medical products.\u003c\/p\u003e","brand":"BMJ Books","offers":[{"title":"Default Title","offer_id":47989931081957,"sku":"NP9780727917805","price":81.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780727917805.jpg?v=1761785953","url":"https:\/\/k12savings.com\/products\/regulation-of-medical-products-isbn-9780727917805","provider":"K12savings","version":"1.0","type":"link"}