Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide PDF Download
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Author:
Publisher: Pharmalicensing
ISBN: 1905310110
Category :
Languages : en
Pages : 130
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Book Description
Author:
Publisher: Pharmalicensing
ISBN: 1905310110
Category :
Languages : en
Pages : 130
Get Book Here
Book Description
Author: Martin Fagan
Publisher: NetworkPharma Ltd
ISBN: 1905676034
Category : Drugs
Languages : en
Pages : 24
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Book Description
Author: Magdalena Krekora
Publisher: Kluwer Law International B.V.
ISBN: 9041126422
Category : Law
Languages : en
Pages : 462
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Book Description
Taking 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. 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: and definition of andmedicineand in different jurisdictions; and categories of medicines; and manufacturing and importation regulation in numerous jurisdictions worldwide; and inspection regimes; and good manufacturing practice (GMP); and marketing authorization; and manufacturing documentation; and complaints and product recall; and liability insurance; and protection of trade secrets; and data exclusivity and data protection; and deficiencies and delays; and and recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines 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.
Author: John K. Halvey
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 580
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Book Description
This book walks readers through an outsourcing transaction step-by-step: analyzing the benefits, selecting vendor, structuring the deal, managing the relationship. Provides managers with an organized methodical approach to the often intimidating prospect of relinquising absolute control of every aspect of a company's business.
Author:
Publisher:
ISBN:
Category : Law firms
Languages : en
Pages : 1736
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Book Description
Author: Reita Ghosh
Publisher:
ISBN: 9780855144203
Category : Corporate lawyers
Languages : en
Pages : 1060
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Book Description
Author:
Publisher: Pharmalicensing
ISBN: 1905310250
Category :
Languages : en
Pages : 61
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Book Description
Author:
Publisher:
ISBN:
Category : Corporate lawyers
Languages : en
Pages : 2244
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Book Description
Author:
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1844
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Book Description
Author: Andreas Seiter
Publisher: World Bank Publications
ISBN: 0821383876
Category : Medical
Languages : en
Pages : 240
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Book Description
This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.
