Improving the Regulatory Review Process
. Ed(s): Lumley, C.E.; Walker, Stuart R.
ISBN 10: 0792387066 ISBN 13: 9780792387060
Edité par Kluwer Academic Publishers, 1996
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Description :
Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. The proceedings of the 11th CMR Workshop, held in September 1995 and reproduced in this book, provide an overview of the current review process around the world. Editor(s): Lumley, C.E.; Walker, Stuart R. Series: Centre for Medicines Research Workshop. Num Pages: 172 pages, biography. BIC Classification: MMG; TDCW. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly. Dimension: 297 x 210 x 12. Weight in Grams: 454. . 1996. Hardback. . . . . Books ship from the US and Ireland. N° de réf. du vendeur V9780792387060
Synopsis :
Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.
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Détails bibliographiques
Titre : Improving the Regulatory Review Process
Éditeur : Kluwer Academic Publishers
Date d'édition : 1996
Reliure : Couverture rigide
Etat : New
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Improving the Regulatory Review Process: Industry and Regulatory Initiatives (Centre for Medicines Research Workshop)
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Improving the Regulatory Review Process
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Gebunden. Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is . N° de réf. du vendeur 5971091
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Improving the Regulatory Review Process | Industry and Regulatory Initiatives
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Buch. Etat : Neu. Improving the Regulatory Review Process | Industry and Regulatory Initiatives | C. Lumley (u. a.) | Buch | xx | Englisch | 1996 | Springer | EAN 9780792387060 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu Print on Demand. N° de réf. du vendeur 102532151
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Improving the Regulatory Review Process
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Buch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions. 196 pp. Englisch. N° de réf. du vendeur 9780792387060
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Improving the Regulatory Review Process
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ISBN 13 : 9780792387060
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Buch. Etat : Neu. Neuware -Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 196 pp. Englisch. N° de réf. du vendeur 9780792387060
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Improving the Regulatory Review Process : Industry and Regulatory Initiatives
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ISBN 13 : 9780792387060
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Buch. Etat : Neu. Druck auf Anfrage Neuware - Printed after ordering - Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions. N° de réf. du vendeur 9780792387060
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