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Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional (Record no. 19533)

000 -LEADER
fixed length control field 03011nam a22004095i 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20140310150643.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 120614s2012 xxu| s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781461436829
978-1-4614-3682-9
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS380
Classification number RS190-210
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
Edition number 23
264 #1 -
-- New York, NY :
-- Springer New York :
-- Imprint: Springer,
-- 2012.
912 ## -
-- ZDB-2-SME
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Huml, Raymond A.
Relator term author.
245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE
Title Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional
Medium [electronic resource] /
Statement of responsibility, etc by Raymond A. Huml.
300 ## - PHYSICAL DESCRIPTION
Extent XV, 82 p. 4 illus., 3 illus. in color.
Other physical details online resource.
440 1# - SERIES STATEMENT/ADDED ENTRY--TITLE
Title SpringerBriefs in Pharmaceutical Science & Drug Development,
International Standard Serial Number 1864-8118
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 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.
520 ## - SUMMARY, ETC.
Summary, etc None.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
Topical term or geographic name as entry element Pharmaceutical technology.
Topical term or geographic name as entry element Biomedicine.
Topical term or geographic name as entry element Pharmaceutical Sciences/Technology.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title Springer eBooks
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Printed edition:
International Standard Book Number 9781461436812
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://dx.doi.org/10.1007/978-1-4614-3682-9
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Item type E-Book
Copies
Price effective from Permanent location Date last seen Not for loan Date acquired Source of classification or shelving scheme Koha item type Damaged status Lost status Withdrawn status Current location Full call number
2014-04-05AUM Main Library2014-04-05 2014-04-05 E-Book   AUM Main Library615.19

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