The Resource Pharmaceutical competitive intelligence for the regulatory affairs professional, Raymond A. Huml, (electronic resource)

Pharmaceutical competitive intelligence for the regulatory affairs professional, Raymond A. Huml, (electronic resource)

Label
Pharmaceutical competitive intelligence for the regulatory affairs professional
Title
Pharmaceutical competitive intelligence for the regulatory affairs professional
Statement of responsibility
Raymond A. Huml
Creator
Contributor
Provider
Subject
Language
eng
Summary
None
Member of
Cataloging source
GW5XE
http://library.link/vocab/creatorName
Huml, Raymond A
Image bit depth
0
LC call number
HD9665.5
LC item number
.H86 2012
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
SpringerLink
Series statement
SpringerBriefs in Pharmaceutical Science & Drug Development,
http://library.link/vocab/subjectName
  • Pharmaceutical industry
  • Business intelligence
  • Drugs
  • BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology
  • Business intelligence
  • Drugs
  • Pharmaceutical industry
  • Médecine
Label
Pharmaceutical competitive intelligence for the regulatory affairs professional, Raymond A. Huml, (electronic resource)
Instantiates
Publication
Antecedent source
mixed
Bibliography note
Includes bibliographical references and index
Color
not applicable
Contents
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. Table of contents: Introduction to Competitive Intelligence -- Overall Perspective of Due Diligence Investigations and Processes -- The Regulatory Functional Review – Primary Roles -- The On-Site Due Diligence/Data Room Meeting and Interactions with other Functional Area Experts -- Intellectual Property -- The Final Report -- Competitive Intelligence Summary
Dimensions
unknown
Extent
1 online resource.
File format
multiple file formats
Form of item
  • online
  • electronic
Isbn
9781461436829
Level of compression
uncompressed
Other control number
9786613765604
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
Stock number
376560
System control number
  • (OCoLC)796934947
  • (OCoLC)ocn796934947
Label
Pharmaceutical competitive intelligence for the regulatory affairs professional, Raymond A. Huml, (electronic resource)
Publication
Antecedent source
mixed
Bibliography note
Includes bibliographical references and index
Color
not applicable
Contents
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. Table of contents: Introduction to Competitive Intelligence -- Overall Perspective of Due Diligence Investigations and Processes -- The Regulatory Functional Review – Primary Roles -- The On-Site Due Diligence/Data Room Meeting and Interactions with other Functional Area Experts -- Intellectual Property -- The Final Report -- Competitive Intelligence Summary
Dimensions
unknown
Extent
1 online resource.
File format
multiple file formats
Form of item
  • online
  • electronic
Isbn
9781461436829
Level of compression
uncompressed
Other control number
9786613765604
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
Stock number
376560
System control number
  • (OCoLC)796934947
  • (OCoLC)ocn796934947

Library Locations

  • African Studies LibraryBorrow it
    771 Commonwealth Avenue, 6th Floor, Boston, MA, 02215, US
    42.350723 -71.108227
  • Alumni Medical LibraryBorrow it
    72 East Concord Street, Boston, MA, 02118, US
    42.336388 -71.072393
  • Astronomy LibraryBorrow it
    725 Commonwealth Avenue, 6th Floor, Boston, MA, 02445, US
    42.350259 -71.105717
  • Fineman and Pappas Law LibrariesBorrow it
    765 Commonwealth Avenue, Boston, MA, 02215, US
    42.350979 -71.107023
  • Frederick S. Pardee Management LibraryBorrow it
    595 Commonwealth Avenue, Boston, MA, 02215, US
    42.349626 -71.099547
  • Howard Gotlieb Archival Research CenterBorrow it
    771 Commonwealth Avenue, 5th Floor, Boston, MA, 02215, US
    42.350723 -71.108227
  • Mugar Memorial LibraryBorrow it
    771 Commonwealth Avenue, Boston, MA, 02215, US
    42.350723 -71.108227
  • Music LibraryBorrow it
    771 Commonwealth Avenue, 2nd Floor, Boston, MA, 02215, US
    42.350723 -71.108227
  • Pikering Educational Resources LibraryBorrow it
    2 Silber Way, Boston, MA, 02215, US
    42.349804 -71.101425
  • School of Theology LibraryBorrow it
    745 Commonwealth Avenue, 2nd Floor, Boston, MA, 02215, US
    42.350494 -71.107235
  • Science & Engineering LibraryBorrow it
    38 Cummington Mall, Boston, MA, 02215, US
    42.348472 -71.102257
  • Stone Science LibraryBorrow it
    675 Commonwealth Avenue, Boston, MA, 02445, US
    42.350103 -71.103784
Processing Feedback ...