書目名稱 | Improving the Regulatory Review Process | 副標(biāo)題 | Industry and Regulat | 編輯 | Cyndy Lumley (Associate Director),Stuart R. Walker | 視頻video | http://file.papertrans.cn/463/462845/462845.mp4 | 叢書名稱 | Centre for Medicines Research Workshop | 圖書封面 |  | 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 | 關(guān)鍵詞 | assessment; drug; drug development; efficiency; research | 版次 | 1 | doi | https://doi.org/10.1007/978-94-009-1788-0 | isbn_softcover | 978-94-010-7297-7 | isbn_ebook | 978-94-009-1788-0 | copyright | Kluwer Academic Publishers 1996 |
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