| 书目名称 | Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional |
| 编辑 | Raymond A. Huml |
| 视频video | http://file.papertrans.cn/746/745537/745537.mp4 |
| 概述 | Provides a broad overview of the topic.Includes supplementary material: |
| 丛书名称 | SpringerBriefs in Pharmaceutical Science & Drug Development |
| 图书封面 |  |
| 描述 | This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product’s lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and |
| 出版日期 | Book 2012 |
| 关键词 | due diligence; intellectual property; patent protection; product-based risk; regulations |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-1-4614-3682-9 |
| isbn_softcover | 978-1-4614-3681-2 |
| isbn_ebook | 978-1-4614-3682-9Series ISSN 1864-8118 Series E-ISSN 1864-8126 |
| issn_series | 1864-8118 |
| copyright | The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Science+Busines |
|Archiver|手机版|小黑屋|
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