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Guide To EU Pharmaceutical Regulatory Law - Bird
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Bird:
Guide To EU Pharmaceutical Regulatory Law - pocketboek

ISBN: 904112845X

[SR: 8433097], Paperback, [EAN: 9789041128454], Kluwer Law International, Kluwer Law International, Book, [PU: Kluwer Law International], Kluwer Law International, In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny of the urgent and essential role such products play in human development and welfare worldwide. This incomparably useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, its expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering clear unambiguous guidance in matters of regulatory law at every stage. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe A--- from its underlying rationales to the relevant committees and agencies - each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: * obtaining a marketing authorisation; * stages and standards for creating a product dossier; * clinical trials; * how and when an abridged procedure can be used; * criteria for conditional marketing authorisations; * generic products and 'essential similarity'; * paediatric use and the requisite additional trials; * biologicals and 'biosimilars'; * homeopathic and herbal medicines; * reporting procedures; * notification of adverse events; * parallel trade; * relevant competition law and intellectual property rights; and * advertising. Especially useful features include national variation charts in many of the chapters for eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK), sample forms and URLs for the most important Directives, Lawyers, both in-house at pharmaceutical firms and in private practice, will welcome this one-of-a-kind book. Its value for those who find themselves having to advise a client on bringing a medicinal product or medical device to market - and on the relevant continuing rights and obligations - is immeasurable. The book will also be of great interest and assistance to regulatory advisers., 173488, Intellectual Property, 10812, Communications, 10866, Entertainment, 10960, Patent, Trademark & Copyright, 10777, Law, 1000, Subjects, 283155, Books, 10898, Foreign & International Law, 10777, Law, 1000, Subjects, 283155, Books, 21, Reference, 11444, Almanacs & Yearbooks, 11448, Atlases & Maps, 2572, Careers, 11626, Catalogs & Directories, 11472, Consumer Guides, 11475, Dictionaries & Thesauruses, 11713, Encyclopedias & Subject Guides, 11823, English as a Second Language, 11761, Etiquette, 11773, Foreign Language Study & Reference, 11880, Genealogy, 11902, Quotations, 8975382011, Survival & Emergency Preparedness, 5267710011, Test Preparation, 11970, Words, Language & Grammar, 5267707011, Writing, Research & Publishing Guides, 1000, Subjects, 283155, Books, 468222, Law, 491506, Business Law, 491510, Constitutional Law, 491512, Criminal Law, 491516, Legal Reference, 491514, Tax Law, 465600, New, Used & Rental Textbooks, 2349030011, Specialty Boutique, 283155, Books

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Guide to Eu Pharmaceutical Regulatory Law - Bird, Sally Shorthose
(*)
Bird, Sally Shorthose:
Guide to Eu Pharmaceutical Regulatory Law - pocketboek

ISBN: 904112845X

Paperback, [EAN: 9789041128454], Kluwer Law Intl, Kluwer Law Intl, Book, [PU: Kluwer Law Intl], Kluwer Law Intl, 929122, Intellectual Property, 929128, Communications, 929130, Entertainment, 929126, Patent, Trademark & Copyright, 927730, Law, 927726, Subjects, 916520, Books, 929132, International Law, 16254631, European Union, 16036021, International Courts, 16036011, International Disputes, 16036031, Private Law, 927730, Law, 927726, Subjects, 916520, Books, 15306601, Law, 15306611, Business Law, 15306631, Constitutional Law, 15306641, Criminal Law, 15306661, Legal Reference, 15306651, Tax Law, 15115321, Textbooks, 927726, Subjects, 916520, Books

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Guide to Eu Pharmaceutical Regulatory Law - Bird, Sally Shorthose
(*)
Bird, Sally Shorthose:
Guide to Eu Pharmaceutical Regulatory Law - pocketboek

ISBN: 904112845X

[SR: 2600011], Taschenbuch, [EAN: 9789041128454], Kluwer Law International, Kluwer Law International, Book, [PU: Kluwer Law International], Kluwer Law International, 63951011, Geistiges Eigentum, 63925011, Recht, 54071011, Genres, 52044011, Fremdsprachige Bücher, 64026011, Internationales Recht, 63925011, Recht, 54071011, Genres, 52044011, Fremdsprachige Bücher

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Guide To EU Pharmaceutical Regulatory Law - Bird
(*)
Bird:
Guide To EU Pharmaceutical Regulatory Law - pocketboek

ISBN: 9789041128454

ID: 599798991

Kluwer Law International. Paperback. New. Buy with confidence. Excellent Customer Service & Return policy. Ships Fast. Expedite Shipping Available., Kluwer Law International

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Guide To EU Pharmaceutical Regulatory Law - Bird
(*)
Bird:
Guide To EU Pharmaceutical Regulatory Law - pocketboek

2010, ISBN: 904112845X

ID: 17489619219

[EAN: 9789041128454], Neubuch, [PU: Kluwer Law International]

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Bijzonderheden over het boek
Guide to Eu Pharmaceutical Regulatory Law

In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage.

Gedetalleerde informatie over het boek. - Guide to Eu Pharmaceutical Regulatory Law


EAN (ISBN-13): 9789041128454
ISBN (ISBN-10): 904112845X
pocket book
Verschijningsjaar: 2010
Uitgever: Kluwer Law International
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Gewicht: 1,008 kg
Taal: eng/Englisch

Boek bevindt zich in het datenbestand sinds 12.02.2011 14:40:46
Boek voor het laatst gevonden op 23.09.2016 20:38:23
ISBN/EAN: 9789041128454

ISBN - alternatieve schrijfwijzen:
90-411-2845-X, 978-90-411-2845-4


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