Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations

by Mindy J. Allport-settle

Overview

Topics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814
* FDA and ICH GCP Standards for Clinical Research
* Form FDA 1572-Statement of Investigator
* Informed Consent
* Patient Recruitment
* State Standards and GCP
* Source Data/Documentation
* Investigator/Site Requirements
* Clinical Monitoring
* Clinical Study Safety Reporting
* Clinical Trial Protocols/Protocol Changes/Protocol Violations
* Institutional Review Boards
* Quality Assurance Activities/Study Auditing/FDA Inspections
* Investigational Drug Accountability, Administration, and Labeling

Product Details

BN ID:	2940011814839
Publisher:	PharmaLogika
Publication date:	08/26/2010
Series:	Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Referen , #1
Sold by:	Barnes & Noble
Format:	eBook
Pages:	710
File size:	518 KB

About the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education.

Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology.

Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.