This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicines and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries and in government agencies involved in the control of medicines and medical devices.NICE will also advise how the NHS could obtain best value-for-money without reducing quality of patient care. ... This is supported by guidelines from the Faculty of Dental Surgery and from the Scottish Inter-Collegiate Network, and by a criticalanbsp;...
|Title||:||Development and Control of Medicines and Medical Devices|
|Author||:||Robin J. Harman|