02965nam 2200625 450 991014425340332120170816111605.03-527-64471-71-281-94710-597866119471013-527-62303-53-527-62304-3(CKB)1000000000556677(EBL)481855(OCoLC)283799106(SSID)ssj0000200553(PQKBManifestationID)11184117(PQKBTitleCode)TC0000200553(PQKBWorkID)10220925(PQKB)11112495(MiAaPQ)EBC481855(EXLCZ)99100000000055667720160816h20082008 uy 0engur|n|---|||||txtccrMedical product regulatory affairs pharmaceuticals, diagnostics, medical devices /by John J. Tobin and Gary WalshWeinheim, [Germany] :Wiley-Blackwell,2008.©20081 online resource (299 p.)Description based upon print version of record.3-527-31877-1 Includes bibliographical references at the end of each chapters and index.Medical Product Regulatory Affairs; Contents; Preface; 1 The Aims and Structure of Regulations; 2 Regulatory Strategy; 3 Drug Discovery and Development; 4 Non-Clinical Studies; 5 Clinical Trials; 6 Marketing Authorisation; 7 Authorisation of Veterinary Medicines; 8 Variations to the Drug Authorisation Process; 9 Medical Devices; 10 Authorisation of Medical Devices; 11 Good Manufacturing Practice (GMP); 12 Oversight and Vigilance; IndexWritten in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.Everything pharmacologDrugsLaw and legislationPharmacyLaw and legislationMedical instruments and apparatusLaw and legislationElectronic books.DrugsLaw and legislation.PharmacyLaw and legislation.Medical instruments and apparatusLaw and legislation.344.041344.0416Tobin Jack(John J.),977324Walsh GaryMiAaPQMiAaPQMiAaPQBOOK9910144253403321Medical product regulatory affairs2226370UNINA