Table of Contents

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

About the Author

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.