Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.
1. Introduction to Regulated Products
2. Regulatory Agencies of the ICH: Authorities, Structures and
Functions
3. Drugs
4. Biologics
5. Medical Devices and Diagnostic Products
6. Combination Products, Borderline Products and Companion
Diagnostics
7. Food
8. Veterinary Products
9. Dietary Supplements
10. Cosmetics
11. Tobacco Products
12. Quality
Eunjoo Pacifici received her doctor of pharmacy and PhD in
toxicology from the University of Southern California. She
conducted her graduate research in the laboratory of Dr. Alex
Sevanian in the Institute for Toxicology at USC, where she studied
the mechanism of oxidative damage and repair in endothelial cell
membrane.
After receiving her graduate degrees, Pacifici worked at Amgen and
gained experience in conducting clinical research with a special
focus on Asia Pacific and Latin America regions. She initially
worked in the clinical development group managing U.S.
investigational sites and central laboratories and then went on to
work in the Asia Pacific/Latin America group interfacing with local
clinical and regulatory staff in Japan, People’s Republic of China,
Taiwan and Mexico. She represented regional clinical and regulatory
views on therapeutic product development teams and led satellite
task forces in order to align local efforts with U.S. activities.
Susan Bain, DRSc, is an assistant professor of Regulatory and
Quality Sciences at USC and previously was a professor of practice
and program director for clinical, regulatory and quality at Keck
Graduate Institute (KGI) and adjunct professor of practice and
concentration coordinator for clinical and regulatory in KGI’s
School of Pharmacy.
Dr. Bain is an accomplished quality and regulatory professional
with experience in the medical device, pharmaceutical and
biotechnology industries. She has a diverse regulatory compliance
background in a broad range of FDA-regulated industries.
She received a doctorate of regulatory science, a master of science
in regulatory science from USC and a bachelor of science in
biological science from Cal Poly, Pomona. She holds a graduate
certificate in effective supervision from Cal Poly Pomona and is a
member of the Orange County Regulatory Association, DIA, PDA, AGRE
and RAPS.
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