Lavoisier S.A.S.
14 rue de Provigny
94236 Cachan cedex
FRANCE

Heures d'ouverture 08h30-12h30/13h30-17h30
Tél.: +33 (0)1 47 40 67 00
Fax: +33 (0)1 47 40 67 02


Url canonique : www.lavoisier.fr/livre/autre/an-overview-of-fda-regulated-products/descriptif_3782035
Url courte ou permalien : www.lavoisier.fr/livre/notice.asp?ouvrage=3782035

0 article 

 Frais de port 0,01€*

Exclusivité web : à partir de 35 euros d’achat, frais de port à 1 centime pour les expéditions vers la France métropolitaine, la Suisse et l’UE avec Colissimo ou GLS

An Overview of FDA Regulated Products From Drugs and Cosmetics to Food and Tobacco

Langue : Anglais

Coordonnateurs : Pacifici Eunjoo, Bain Susan

Couverture de l’ouvrage An Overview of FDA Regulated Products

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

Professors and graduate students enrolled in regulatory science/affairs, pharmacy and pharmaceutical science, medicine, biomedical engineering, biotechnology, translational science, food science and veterinary science programs; early career professionals in the regulated industry, entrepreneurs in life sciences and medical technologies

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.
  • Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations
  • Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference
  • Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Date de parution :

Ouvrage de 280 p.

19x23.4 cm

Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).

Prix indicatif 98,24 €

Ajouter au panier