Esta edición ISBN ya no está disponible.Ver todas las copias de esta edición ISBN.
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 style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
FDA Regulatory Affairs:
Three all-new chapters cover:
DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his Ph.D. in Law, Policy, and Society at Northeastern University, Boston, Massachusetts, USA. He is an active member of several professional organizations, including the American Association of Colleges of Pharmacy and the American Pharmaceutical Association. A national speaker and invited lecturer, Dr. Pisano was the recipient of the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society in 2000. He has developed several courses and programs at the Massachusetts College of Pharmacy and Health Sciences in such areas as health policy, pharmacy and drug law, and regulatory affairs. Dr. Pisano, along with coeditor Dr. David S. Mantus, is also the editor of the first edition of Informa Healthcare’s FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics.
DAVID S. MANTUS is Vice President of Regulatory Affairs and Program Management, Cubist Pharmaceuticals, Inc., Lexington; Adjunct Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences, Boston; and President, C After D Inc., Boston, Massachusetts, USA. Dr. Mantus received his Ph.D. in Chemistry from Cornell University, Ithaca, New York, USA. He is an active member of the Regulatory Affairs Professional Society and the American Chemical Society and is a frequent presenter and lecturer at national conferences on biologics and biotechnology, regulatory affairs, and vaccine development. Dr. Mantus has also served as chairperson for several conferences, including "Outsourcing Regulatory Affairs" and "Vaccine Development for the 21st Century."
"Sobre este título" puede pertenecer a otra edición de este libro.
Descripción CRC Press, 2008. Hardcover. Condición: New. 2. Nº de ref. del artículo: DADAX1420073540
Descripción CRC Press, 2008. Hardcover. Condición: New. Never used!. Nº de ref. del artículo: P111420073540
Descripción CRC Press, 2008. Condición: New. book. Nº de ref. del artículo: M1420073540
Descripción CRC Press, 2018. Hardback. Condición: NEW. 9781420073546 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Print on Demand title, produced to the highest standard, and there would be a delay in dispatch of around 10 working days. For all enquiries, please contact Herb Tandree Philosophy Books directly - customer service is our primary goal. Nº de ref. del artículo: HTANDREE0249514
Descripción CRC Press 2008-08-11, 2008. Condición: New. Brand new book, sourced directly from publisher. Dispatch time is 4-5 working days from our warehouse. Book will be sent in robust, secure packaging to ensure it reaches you securely. Nº de ref. del artículo: NU-TNFPD-00108780
Descripción CRC Press, 2008. Hardcover. Condición: New. 2. Ships with Tracking Number! INTERNATIONAL WORLDWIDE Shipping available. Buy with confidence, excellent customer service!. Nº de ref. del artículo: 1420073540n