Medical Product Regulatory Affairs - John J. Tobin

Medical Product Regulatory Affairs Hands-on Guide Through The Jungle Of Medical Regulatory Affairs For Every Professional Involved In Bringing Products To Market Based On A Module Prepared By The Authors For An Msc Course Offered By The University Of Limerick, Ireland, Medical Product Regulatory Affairs Is A Comprehensive And Practical Guide On How Pharmaceutical And Medical Devices Are Regulated Within The Major Global Markets. The Second Edition Builds On The Success Of The First With An Even Wider Scope And Full Coverage Of Eu Regulations On The Safe Use Of Medical Devices. 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.