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Titlebook: Improving the Regulatory Review Process; Industry and Regulat Cyndy Lumley (Associate Director),Stuart R. Walker Book 1996 Kluwer Academic

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书目名称Improving the Regulatory Review Process
副标题Industry and Regulat
编辑Cyndy Lumley (Associate Director),Stuart R. Walker
视频video
丛书名称Centre for Medicines Research Workshop
图书封面Titlebook: Improving the Regulatory Review Process; Industry and Regulat Cyndy Lumley (Associate Director),Stuart R. Walker Book 1996 Kluwer Academic
描述Regulatory review is the last major development hurdle thatmust be passed by a new medicine before it reaches the market. At atime when pharmaceutical companies are reviewing their R&D strategies,and attempting to reduce drug development times, it is extremelyimportant that the review process is made as efficient as possible.The 11th CMR Workshop, held in September 1995, provided theopportunity for regulatory authority and industry personnel fromEurope, North America, Australia and Japan to openly discuss views andexchange experiences on the subject of improving the review process.The proceedings of this meeting provide a comprehensive overview ofthe current review process around the world. The contributors describethe present situation and highlight company strategies and regulatoryinitiatives to improve the review process. This volume also summarisesthe suggestions that were developed by the participants, covering manyfacets of this process, including the quality and size of the dossier,dialogue, submission strategies, feedback and the response toquestions.
出版日期Book 1996
关键词assessment; drug; drug development; efficiency; research
版次1
doihttps://doi.org/10.1007/978-94-009-1788-0
isbn_softcover978-94-010-7297-7
isbn_ebook978-94-009-1788-0
copyrightKluwer Academic Publishers 1996
The information of publication is updating

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