Development and Control of Medicines and Medical Devices
Harman, Robin J
Robin J Harman - Independent pharmaceutical and regulatory consultant
This book 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.
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
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
1. EU Regulatory Authority Addresses
2. WMA Declaration of Helsinki
3. WHO Member States By Region
01-Jun-07, Medical and Pharmaceutical Network of the Institute of Translating and Interpreting - Newsletter
'The book describes those processes and tests that pharmaceutical products and medical devices must undergo to demonstrate their quality, safety and efficacy prior to obtaining regulatory approval. Although a lot of the material...can be found (with patience) on the Internet, the great advantage of the book is that it brings it all together in a single volume review...it is well produced and has a good index.'
Newsletter of the Medical and Pharmaceutical Network of the Institute of Translating and Interpreting
'Chapters are clearly written, well organized, and quite detailed...recommended for libraries that serve schools of pharmacy and for anyone working in the pharmaceutical or medical device industries or in government agencies responsible for regulating these industries.'
Victoria Tamborinno, Ass. Prof. And ILL Librarian, St. John's University Library01-Dec-04, Drug Development and Industrial Pharmacy:
'The information is presented in a clear and concise manner and references to various guidelines and directives will assist the reader in identifying additional resource materials. With the global nature of the pharmaceutical industry, all scientists with regulatory responsibilities and especially those involved in the UK and Europeam markets will find this text useful.'
Linda A. Felton, University of New Mexico, USA
ISBN 978 0 85369 567 7
Published Jul 2004
244 x 172mm (272pp)