Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices /: pharmaceuticals, diagnostics, medical devices. ([2011?])

• Record Type: Book
• Further Information: Note: John J. Tobin and Gary Walsh.
• Authors: Tobin, Jack (John J.); (Biochemist), Walsh, Gary
• Contents: 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; Index.
• Publisher Details: Weinheim : Wiley-Blackwell
• Publication Date: 2011
• Copyright Date: 2008
• Extent: 1 online resource, illustrations
• Subjects: 344.0416; Drugs -- Law and legislation; Pharmacy -- Law and legislation; Medical instruments and apparatus -- Law and legislation; LAW -- Medical Law & Legislation; Drugs -- Law and legislation; Medical instruments and apparatus -- Law and legislation; Pharmacy -- Law and legislation; Legislation, Drug -- Europe; Legislation, Drug -- United States; Device Approval -- Europe; Device Approval -- United States; Equipment and Supplies -- Europe; Legislation, Drug -- United States; Legislation, Pharmacy -- Europe; Legislation, Pharmacy -- United States; Device Approval -- United States; Equipment and Supplies -- United States; Equipment and Supplies -- Europe; Legislation, Pharmacy -- United States; Legislation, Drug -- Europe; Legislation, Drug; Device Approval; Equipment and Supplies; Legislation, Pharmacy; Legislation, Pharmacy -- Europe; Device Approval -- Europe; Equipment and Supplies -- United States; Legislation, Drug; Device Approval; Equipment and Supplies; Legislation, Pharmacy; Europe; United States; Electronic books
• Languages: English
• ISBNs: 9783527644711; 3527644717
• Notes: Note: Includes bibliographical references and index.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.