A Learner's Guide to Good Practices in Clinical Research: Simplified Version of Clinical Research to Help Understand the Quality and Compliance ... for Beginners: Right Step in Right Direction - Couverture souple

Pandey PH D, Jaya

Couverture souple

ISBN 10 : 1452811733 ISBN 13 : 9781452811734

Editeur : Createspace Independent Publishing Platform, 2010

Synopsis

The main premise of this book is to give an insight to those who have decided to take their first steps in the direction of learning and establishing themselves in the ever emerging field of clinical trials conducted for Life Sciences/ Medical Device/ Pharmaceutical Industry with a focus on the basic understanding of the principles and terminology involved in clinical trials. Main focus of the book remains on Quality Control, Quality Assurance and Regulatory Compliance as applied in Pharam/ Biotech/Medical Device Industry.

A propos du livre

À propos de l?auteur

Jaya Pandey, Ph.D. (1993) with over 15 years of experience in Medical Sciences has worked extensively in India, Indonesia, Singapore and United States and in 2006 started her Quality & Compliance consulting in San Francisco Bay Area in California as a Principal at BayBiotech.NET . Since then, she has done a diploma course in Quality Assurance and Regulatory Affairs from Kriger Research Center and has worked with small to mid-size companies and academic institutes for preparing various Quality/ Regulatory compliance related documents for clinical studies. Currently she is also member of Regulatory Affairs Professional Society. Jaya has prepared and delivered on-line content through her regular blogs (http: //baybiotechnet.blogspot.com/) During her Ph.D. she co-authored two scientific publications in Journal of Clinical Endocrinology and Metabolism and Pediatric Surgery International along with a group of scientists and professors at the Institute. During her post-doctoral fellowship in India, she was engaged in establishing the scientific and administrative aspects of a project entitled 'Characterization of Immunological Response in Hepatitis E Virus Infection' at Sanjay Gandhi Post Graduate Institute of Medical Sciences. During her short visit to Department of Biochemistry at National University of Singapore and Eijkman Institute of Molecular Biology in Jakarta, Indonesia, she actively contributed to scientific aspect of characterization of malarial parasite proteins using molecular biology techniques. After moving to US in 1999, Jaya took training in the area of Bioinformatics from University of California, Santa Cruz and subsequently joined as a Research Associate at Children's Hospital of Los Angeles(CHLA) where she worked on anthrax toxin. During her work in the hospital set-up she was trained on HIPAA regulations, on in silico modeling from Scripps Research Institute, La Jolla, CA as well as on Good Clinical Practices at University of California at Irvine. During her work at CHLA, she published in journals as Microbes & Infection and Internet Electronic Journal of Molecular Design. Between 2004- 2006, Jaya worked as consultant for companies and was engaged in IND filing and was trained on Good Laboratory Practices, Safe Harbor as well as Regulatory Compliance. Currently, Jaya lives in Palo Alto, California, with her husband and two kids.

Détails de l'édition

• Éditeur: Createspace Independent Publishing Platform
• Date d'édition: 2010
• Langue: anglais
• ISBN 10: 1452811733
• ISBN 13: 9781452811734
• Reliure: Broché
• Nombre de pages: 240
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible