LEADER 03916nam  22006255  450 
001 9910300213903321
005 20200701143525.0
010   $a3-319-17590-4
024 7 $a10.1007/978-3-319-17590-4
035   $a(CKB)3710000000412177
035   $a(EBL)2094746
035   $a(SSID)ssj0001501664
035   $a(PQKBManifestationID)11848060
035   $a(PQKBTitleCode)TC0001501664
035   $a(PQKBWorkID)11446216
035   $a(PQKB)11268492
035   $a(DE-He213)978-3-319-17590-4
035   $a(MiAaPQ)EBC2094746
035   $a(PPN)186026552
035   $a(EXLCZ)993710000000412177
100   $a20150506d2015      u|         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aPharmaceutical Regulatory Environment $eChallenges and Opportunities in the Gulf Region /$fby Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
205   $a1st ed. 2015.
210  1$aCham :$cSpringer International Publishing :$cImprint: Adis,$d2015.
215   $a1 online resource (246 p.)
300   $aDescription based upon print version of record.
311   $a3-319-17589-0 
320   $aIncludes bibliographical references at the end of each chapters.
327   $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.
330   $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, if fully implemented, could have a significant impact on patients? access 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.
606   $aPublic health
606   $aChemotherapy
606   $aPublic Health$3https://scigraph.springernature.com/ontologies/product-market-codes/H27002
606   $aPharmacotherapy$3https://scigraph.springernature.com/ontologies/product-market-codes/H69000
615  0$aPublic health.
615  0$aChemotherapy.
615 14$aPublic Health.
615 24$aPharmacotherapy.
676   $a610
676   $a613
676   $a614
676   $a615.1
700   $aAl-Essa$b Reem K$4aut$4http://id.loc.gov/vocabulary/relators/aut$01060553
702   $aAl-Rubaie$b Mohammed$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aWalker$b Stuart$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aSalek$b Sam$4aut$4http://id.loc.gov/vocabulary/relators/aut
906   $aBOOK
912   $a9910300213903321
996   $aPharmaceutical Regulatory Environment$92514133
997   $aUNINA