000			03397nam a22003855i 4500
001			82391
003			ES-MaUEC
005			20230207040409.0
007			cr nn 008mamaa
008			150506s2015 gw | s |||| 0|eng d
020			_a9783319175904
024	7		_a10.1007/978-3-319-17590-4 _2doi
050		4	_aRS67.M628 _b2015 EB
100	1		_aAl-Essa, Reem K. _995299 _0Local
245	1	0	_aPharmaceutical Regulatory Environment : _bChallenges and Opportunities in the Gulf Region _cby Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek.
260			_aCham _bSpringer International Publishing _bImprint: Adis _c2015.
300			_a1 recurso en línea (XIII, 236 páginas) _b79 ilustraciones en color
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_a1. Overview of Medicines Regulatory Systems in the Gulf Region -- 2. The Regulatory Review Process in the Gulf Region -- 3. Regulatory Review Times in the Gulf Region -- 4. Quality Measures in the Gulf Regulatory Practices -- 5. The Current Status of the Common Technical Document -- 6. The Current Status of Drug Safety and Pharmacovigilance -- 7. The Centralized Regulatory Review in the Gulf Region -- 8. The Gulf States Assessment and Experience With the Centralised Procedure -- 9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure -- 10. Proposal For an Improved Centralized Regulatory System -- 11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions -- 12. The Regulatory Dilemma in the Gulf Region: The Way Forward.
520	3		_aThe Middle East represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which,Â{u0A66} fully implemented, could have a significant impact on patientsâ€{u0863}cess to new medicines. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
710	2		_aSpringerLink (Online service) _0Local _9106996
942			_2lcc _cLE
650		7	_aFarmacoterapia _0 _2embne _9671142
650	2	7	_aFarmacoterapia _0 _2embne _9671142
700	1		_aAl-Rubaie, Mohammed _0Local _995300
700	1		_aWalker, Stuart. _995191 _0Local
700	1		_aSalek, Sam. _936810 _0comprobar BNE20041056877
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-17590-4 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12910314 _b10-10-17 _c10-02-16
988			_aSpringer_Medicine_2015
998			_am _a_alco _a_vill _b - - _cm _dz _e- _feng _ggw _h0
945			_aRS67.M628 A447 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i1157799x _z06-04-17
999			_c82391 _d82391 _x1