EAN: 9781461436812

SPRINGERBRIEFS IN PHARMACEUTICAL SCIENCE & DRUG...

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 regulatory affairs professionals in other regions.

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