Medical Product Regulatory Affairs

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.

Medical Product Regulatory Affairs

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

More Books:

Medical Product Regulatory Affairs
Language: en
Pages: 297
Authors: John J. Tobin, Gary Walsh
Categories: Science
Type: BOOK - Published: 2011-08-24 - Publisher: John Wiley & Sons

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory
Medical Product Regulatory Affairs
Language: en
Pages: 297
Authors: John J. Tobin, Gary Walsh
Categories: Science
Type: BOOK - Published: 2008-09-02 - Publisher: John Wiley & Sons

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory
FDA Regulatory Affairs
Language: en
Pages: 464
Authors: Douglas J. Pisano, David S. Mantus
Categories: Medical
Type: BOOK - Published: 2008-08-11 - Publisher: CRC Press

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free
Medical Regulatory Affairs
Language: en
Pages: 806
Authors: Jack Wong, Raymond K. Y. Tong
Categories: Medical
Type: BOOK - Published: 2022-01-27 - Publisher: CRC Press

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration
Handbook of Medical Device Regulatory Affairs in Asia
Language: en
Pages: 616
Authors: Jack Wong, Raymond Tong Kaiyu
Categories: Medical
Type: BOOK - Published: 2013-03-27 - Publisher: CRC Press

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful