The Global GCP Compliance Report 2006: US, EU, and JapanBarnett Educational ServicesJanuary 1, 2006 180 Pages - SKU: BNT2406789 |
| Countries covered: Japan, United States, Europe As clinical trials are becoming more global in nature and standards for clinical trial conduct are becoming more harmonized, this just-released report presents a first-of-its kind, systematic study of GCP compliance in the world's major markets. Gain exclusive access to detailed data analyses of GCP compliance trends internationally, profiles of GCP compliance programs within several of the world's key regulatory agencies, and in-depth interviews with GCP compliance officials and GCP field inspectors! Plus, gain access to the largest compendium of GCP compliance trends and data ever compiled! Learn exactly where regulators such as the FDA, EMEA, US OHRP, UK MHRA, and Japan's PMDA are finding GCP problems, and what their GCP compliance "hot spots" are today. In The Global GCP Compliance Report, you'll gain access to the following in-depth profiles, compliance data, and interviews: FDA GCP Compliance Programs for Drugs, Biologics, and Medical Devices Interview with the EMEA's GCP Compliance Administrator Fergus Sweeney, Ph.D. The Largest Collection of International GCP Compliance Data Anywhere US OHRP Compliance Program/Data for Government-sponsored Research UK MHRA's GCP Compliance Program Japan's PMDA's GCP Compliance Program and Trend Data Interview with FDA Bioresearch Monitoring Specialist/Inspector Mike Rashti Interview with FDA CDRH (Devices) BIMO Director Michael Marcarelli Interview with FDA CBER (Biologics) BIMO Branch Chief Patricia Holobaugh Complete analyses of investigator, sponsor/monitor, and IRB GCP compliance deficiencies in warning letters/regulatory notifications Interview with FDA's CDER BIMO Director Joanne Rhoads, M.D. Interview with Health Canada's Good Clinical Practices Unit Coordinator Jean Saint-Pierre Please note: The delivery of this report requires Adobe 6 or higher, and the ability to install right management plugin for Adobe. |
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