{"product_id":"medical-product-regulatory-affairs-pharmaceuticals-diagnostics-medical-devices-hardcover","title":"Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices - Hardcover","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eJohn J. Tobin\u003c\/b\u003e (Author), \u003cb\u003eGary Walsh\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eDurch die Behandlung einer Vielzahl unterschiedlicher Produkttypen und der wichtigsten globalen M?rkte ist dieses Lehrwerk genau richtig f?r Kurse rund um Zulassungsfragen medizinischer Ger?te. Eignet sich auch hervorragend als Einf?hrung in das Thema.\u003c\/p\u003e\u003ch3\u003eBack Jacket\u003c\/h3\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eHands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eBased on a module prepared by the authors for an MSc course offered by the University of Limerick, \u003ci\u003eIreland, Medical Product Regulatory Affairs\u003c\/i\u003e is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. \u003c\/p\u003e\u003cp\u003eFollowing a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory\/Clinical\/ Manufacturing Practices. \u003c\/p\u003e\u003cp\u003e\u003ci\u003eMedical Product Regulatory Affairs\u003c\/i\u003e includes information on: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eAims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia\u003c\/li\u003e \u003cli\u003eRegulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation\u003c\/li\u003e \u003cli\u003eDrug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery\u003c\/li\u003e \u003cli\u003eNon-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence\u003c\/li\u003e \u003cli\u003eClinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eThe wide coverage of different product types and the main global markets makes \u003ci\u003eMedical Product Regulatory Affairs\u003c\/i\u003e ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.\u003c\/p\u003e\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003e\u003cb\u003eJohn J. Tobin\u003c\/b\u003e worked for many years and in various capacities within Olympus diagnostica GmbH, a company that employed several 100 people to develop and manufacture in vitro diagnostic reagents. \u003c\/i\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eGary Walsh\u003c\/b\u003e is chair of industrial biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena.\u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 336\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.9 x 9.9 x 6.7 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e January 23, 2024\u003c\/div\u003e\n            ","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":54000447783187,"sku":"9783527333264","price":149.69,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0965\/6300\/3667\/files\/2LP9V6oNL39783527333264.webp?v=1775065684","url":"https:\/\/finduslaw.com\/products\/medical-product-regulatory-affairs-pharmaceuticals-diagnostics-medical-devices-hardcover","provider":"FindUSlaw Bookstore","version":"1.0","type":"link"}