| 書目名稱 | Improving the Regulatory Review Process: Assessing Performance and Setting Targets |
| 編輯 | Neil McAuslane (Research Manager),Stuart Walker (D |
| 視頻video | http://file.papertrans.cn/463/462846/462846.mp4 |
| 叢書名稱 | Centre for Medicines Research Workshop |
| 圖書封面 |  |
| 描述 | At a time when it is becoming usual for medicines to bedeveloped for a global market and pharmaceutical companies areendeavouring to expedite the drug development process, RegulatoryAuthorities are concentrating on improving their efficiency andeffectiveness. Therefore, it is not surprising that questions arebeing asked as to how performance might be measured and comparedbetween different authorities who are now often in receipt of dossiersthat have been submitted to several agencies at the same time. Issuessuch as ‘what target should be set for the review of new medicines?‘a(chǎn)nd `how can quality be assured?‘ are now considered to be of criticalimportance. .The twelfth CMR International Workshop, held in January 1997, providedthe opportunity for Regulatory Authority and industry personnel fromEurope, North America, Australia and Japan to openly discussexperiences and exchange views on how to improve the review process.The proceedings of this meeting provide a comprehensive overview ofthe current review process in different countries and the need forperformance measures and targets. This volume summarises the manysuggestions that were debated at the Workshop, and includes chapterson m |
| 出版日期 | Book 1997 |
| 關鍵詞 | assessment; drug; drug development; efficiency; research |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-94-011-4874-0 |
| isbn_softcover | 978-94-010-6042-4 |
| isbn_ebook | 978-94-011-4874-0 |
| copyright | Kluwer Academic Publishers 1997 |
|Archiver|手機版|小黑屋|
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