000			03189nam a22004455i 4500
001			978-1-4614-3682-9
003			DE-He213
005			20140220083248.0
007			cr nn 008mamaa
008			120614s2012 xxu| s |||| 0|eng d
020			_a9781461436829 _9978-1-4614-3682-9
024	7		_a10.1007/978-1-4614-3682-9 _2doi
050		4	_aRS380
050		4	_aRS190-210
072		7	_aTDCW _2bicssc
072		7	_aMED072000 _2bisacsh
082	0	4	_a615.19 _223
100	1		_aHuml, Raymond A. _eauthor.
245	1	0	_aPharmaceutical Competitive Intelligence for the Regulatory Affairs Professional _h[electronic resource] / _cby Raymond A. Huml.
264		1	_aNew York, NY : _bSpringer New York : _bImprint: Springer, _c2012.
300			_aXV, 82 p. 4 illus., 3 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
490	1		_aSpringerBriefs in Pharmaceutical Science & Drug Development, _x1864-8118
505	0		_aThis 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			_aNone.
650		0	_aMedicine.
650		0	_aPharmaceutical technology.
650	1	4	_aBiomedicine.
650	2	4	_aPharmaceutical Sciences/Technology.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9781461436812
830		0	_aSpringerBriefs in Pharmaceutical Science & Drug Development, _x1864-8118
856	4	0	_uhttp://dx.doi.org/10.1007/978-1-4614-3682-9
912			_aZDB-2-SME
999			_c101424 _d101424