TY  - BOOK
AU  - Tobin,Jack
TI  - Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices 
SN  - 9783527318773 (hbk.) :
AV  - K3636 
U1  - 344.0416 TOB 
PY  - 2008///
CY  - Weinheim, Chichester
PB  - Wiley-VCH, John Wiley [distributor]
KW  - Drugs
KW  - Law and legislation
KW  - Pharmacy
KW  - Medical instruments and apparatus
KW  - Law
KW  - ukslc
KW  - Jurisprudence & general issues
KW  - thema
KW  - Health systems & services
KW  - Medical specialties, branches of medicine
KW  - Public health & safety law
KW  - Pharmacology
N1  - Includes bibliographical references and index; 1.The aims and structure of regulations -- 2.Regulatory strategy -- 3.Drug discovery and development -- 4.Non-cliinical 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
N2  - Written 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
ER  -