Regulation of Medical Products

The Regulation of Medical Products is an essential reference book for pharmaceutical physicians and people in the field of the regulation of medicines, and will be of particular value to pharmaceutical physicians in higher medical training. Chapters are written by worldwide leading authorities on regulatory affairs, and explain the processes and regulations in the major drug producing countries. Contents include:
history of drug regulation; regulation of human medicinal products in the European Union; European regulation of medicinal devices; the supply of unlicensed medicines for particular patient use; controls on NHS medicines; prescribing and expenditure in the UK; the regulation of drug products by the United States FDA; the US FDA in the drug development evaluation and approval process; technical requirements for registration of pharmaceuticals for human use; the ICH process and the common technical document.
This comprehensive and timely text will be an invaluable handbook for anyone prescribing, producing or working with medical products.

Spis treści:
Contributors.
Preface.
Acknowledgements.
The Editors.
History of drug regulation in the UK.
Regulation of human medicinal products in the European Union.
European regulation of medical devices.
The supply of unlicensed medicines for particular patient use.
Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective).
The regulation of therapeutic products in Australia.
Regulatory and clinical trial systems in Japan.
The regulation of drug products by the United States Food and Drug Administration.
The US FDA in the drug development, evaluation, and approval process.
Technical requirements for registration of pharmaceuticals for human use: the ICH process and the Common Technical Document.
Appendix: European guidelines relevant for pharmaceutical physicians.
Index

Okładka tylna:
The Regulation of Medical Products is an essential reference book for pharmaceutical physicians and people in the field of the regulation of medicines, and will be of particular value to pharmaceutical physicians in higher medical training. Chapters are written by worldwide leading authorities on regulatory affairs, and explain the processes and regulations in the major drug producing countries. Contents include:
history of drug regulation; regulation of human medicinal products in the European Union; European regulation of medicinal devices; the supply of unlicensed medicines for particular patient use; controls on NHS medicines; prescribing and expenditure in the UK; the regulation of drug products by the United States FDA; the US FDA in the drug development evaluation and approval process; technical requirements for registration of pharmaceuticals for human use; the ICH process and the common technical document.
This comprehensive and timely text will be an invaluable handbook for anyone prescribing, producing or working with medical products.