Global GCP Compliance Report, The

Summary

The First-Ever Study of Global GCP Clinical Trial Compliance Programs and Trends!
Learn what the FDA, EMEA, OHRP, and Japan's PMDA see as the GCP compliance "hot spots" today! Developed for clinical sponsors and CRAs, clinical trial administrators, clinical compliance officers, clinical investigators and site staff, clinical QA professionals, and other clinical professionals!

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 for those sponsoring and conducting clinical trials.

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 Coordinator Joanne Rhoads, M.D.
Interview with Health Canada's Good Clinical Practices Unit Coordinator Jean Saint-Pierre

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