{"product_id":"contract-manufacturing-of-medicines-magdalena-krekora-9789041126429","title":"Contract Manufacturing of Medicines","description":"\u003cp\u003e \u003cbr\u003eTaking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. \u003c\/p\u003e \u003cp\u003e This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: \u003c\/p\u003e \u003cp\u003e and#8226; definition of and#8216;medicineand#8217; in different jurisdictions; \u003c\/p\u003e \u003cp\u003e and#8226; categories of medicines; \u003c\/p\u003e \u003cp\u003e and#8226; manufacturing and importation regulation in numerous jurisdictions worldwide; \u003c\/p\u003e \u003cp\u003e and#8226; inspection regimes; \u003c\/p\u003e \u003cp\u003e and#8226; good manufacturing practice (GMP); \u003c\/p\u003e \u003cp\u003e and#8226; marketing authorization; \u003c\/p\u003e \u003cp\u003e and#8226; manufacturing documentation; \u003c\/p\u003e \u003cp\u003e and#8226; complaints and product recall; \u003c\/p\u003e \u003cp\u003e and#8226; liability insurance; \u003c\/p\u003e \u003cp\u003e and#8226; protection of trade secrets; \u003c\/p\u003e \u003cp\u003e and#8226; data exclusivity and data protection; \u003c\/p\u003e \u003cp\u003e and#8226; deficiencies and delays; and \u003c\/p\u003e \u003cp\u003e and#8226; recognition and enforcement of judgements. \u003c\/p\u003e \u003cp\u003e A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. \u003c\/p\u003e \u003cp\u003e Indispensable to counsel for pharmaceutical companies of any size, \u003ci\u003eContract Manufacturing of Medicines\u003c\/i\u003e will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime. \u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Magdalena Krekora\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 9041126422\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9789041126429\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Kluwer Law International\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 07\/01\/2008\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 460\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.80lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 1.00d\u003cbr\u003e\u003cbr\u003e\u003cb\u003eReview Citation(s): \u003c\/b\u003e\u003cbr\u003e\u003ci\u003eScitech Book News\u003c\/i\u003e 12\/01\/2008 pg. 10","brand":"Magdalena Krekora","offers":[{"title":"Hardcover","offer_id":48519849640191,"sku":"9789041126429","price":244.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_6c35d16f-1dda-4ff6-990c-c89f55714383.jpg?v=1778739205","url":"https:\/\/www.whiterainbookhouse.com\/products\/contract-manufacturing-of-medicines-magdalena-krekora-9789041126429","provider":"WR Book House","version":"1.0","type":"link"}