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Medical Devices

Development and Control of Medicines and Medical Devices


Publication Date   July 2004
Publisher   Pharmaceutical Press
Product Type   Report
Pages   208
ISBN Number   853695679
Product Code   PHP005
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Price £50.00

approximately: $93 | €63

Summary


New medicines and medical devices undergo a vast array of tests during development to demonstrate their quality, safety and efficacy. Controls also apply to ensure their continued safe use once marketed. Numerous government statutory regulations cover these requirements.

This new title describes these tests and the processes undertaken to bring such products to the market, and the work of the government agencies who ensure products of the highest standards.

Topics include the European registration processes for medicines and medical devices, and the roles of the UK and pan-European regulatory authorities (MHRA and EMEA). Other issues covered are the work of NICE, the importance of the ICH process, and the activities of the US FDA and the WHO in drug and device regulation. Ethical issues in product development are also considered.

Development and Control of Medicines and Medical Devices is an essential reference for those working in the pharmaceutical and medical device industries and in government agencies responsible for the control of medicines and medical devices. It is also an invaluable reference for all students undertaking healthcare studies and for all pharmacists.

Content


Part A: Developing Medicines and Medical Devices
1. Introduction to the Drug Development Process
2. Options in the Registration of Medicinal Products
3. Quality Issues
4. Pharmacotoxicological Studies
5. Clinical Issues
6. Pharmacovigilance
7. Medical Devices and Their Control
8. Ethical Issues

Part B: Organisations Controlling Medicines and Medical Devices
9. MHRA-medicinal Products
10. MHRA-medical Devices
11. The EMEA-supranational Drug Regulation
12. National Institute for Clinical Excellence
13. International Perspectves

Appendices
1. EU Regulatory Authority Addresses
2. WMA Declaration of Helsinki
3. WHO Member States By Region