Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

Nonfiction, Science & Nature, Technology, Engineering, Chemical & Biochemical, Health & Well Being, Medical, Specialties, Pharmacy
Cover of the book Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional by Raymond A. Huml, Springer New York
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Raymond A. Huml ISBN: 9781461436829
Publisher: Springer New York Publication: June 15, 2012
Imprint: Springer Language: English
Author: Raymond A. Huml
ISBN: 9781461436829
Publisher: Springer New York
Publication: June 15, 2012
Imprint: Springer
Language: English

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. ​

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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. ​

More books from Springer New York

Cover of the book Chaos in Switching Converters for Power Management by Raymond A. Huml
Cover of the book Principles of Discontinuous Dynamical Systems by Raymond A. Huml
Cover of the book Exotic Nuclear Excitations by Raymond A. Huml
Cover of the book Celestial Shadows by Raymond A. Huml
Cover of the book Psychoeducational Assessment and Report Writing by Raymond A. Huml
Cover of the book Environmental Adaptations and Stress Tolerance of Plants in the Era of Climate Change by Raymond A. Huml
Cover of the book Soft Computing Approach to Pattern Classification and Object Recognition by Raymond A. Huml
Cover of the book Atlas of Virtual Colonoscopy by Raymond A. Huml
Cover of the book Men Trapped in Men's Bodies by Raymond A. Huml
Cover of the book Global Overshoot by Raymond A. Huml
Cover of the book Treetops at Risk by Raymond A. Huml
Cover of the book Residue Reviews / Rückstands-Berichte by Raymond A. Huml
Cover of the book Nanotechnology Enabled In situ Sensors for Monitoring Health by Raymond A. Huml
Cover of the book Phenology of Ecosystem Processes by Raymond A. Huml
Cover of the book System-Level Validation by Raymond A. Huml
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy