{"product_id":"good-clinical-practice-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-volume-1-regulati-9780982147672","title":"Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulati","description":"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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Mindy J. Allport-Settle\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Pharmalogika\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 08\/26\/2010\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 712\u003cbr\u003e\u003cb\u003eBinding Type:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.06lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 1.42d\u003cbr\u003e\u003cb\u003eISBN:\u003c\/b\u003e 9780982147672\u003cbr\u003e\u003cp\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\u003eMindy Allport-Settle has served 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, product commercialization strategies, operational, project and contract management, 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.\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003eThis title is not returnable\u003c\/i\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Pharmalogika","offers":[{"title":"Paperback","offer_id":40445916971123,"sku":"9.78E+12","price":66.49,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0555\/9255\/0515\/products\/img_8250a555-b52a-4620-9971-80eb33d30052.jpg?v=1663426745","url":"https:\/\/bookstorenmore.com\/products\/good-clinical-practice-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-volume-1-regulati-9780982147672","provider":"Bookstore N More","version":"1.0","type":"link"}