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Changes and Challenges in Foreign Clinical Research April 2011

Course Description 

As the number of clinical research trials conducted outside of the United States increases, the FDA has come under new scrutiny for its ability to monitor and inspect foreign clinical trials. This course will examine the changing landscape of clinical research and how the FDA is adapting its processes to address these challenges. This course will provide models for site selection, site oversight, and preparing foreign clinical research sites for regulatory inspections. Participants will gain a greater understanding of current FDA inspection trends of foreign clinical research sites.

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Learning Objectives 

  • Explore the changing landscape of foreign clinical research
  • Examine current FDA inspection metrics and challenges
  • Review models for selection and oversight of foreign clinical research sites

Who Should Attend 

  • This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, IRB Professionals, Institutional Officials involved in oversight of clinical research, and GCP-Focused Regulatory Affairs Professionals.

Instructor 

Elizabeth Ronk Nelson, M.P.H.

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Course Length Time 

2 hours; 9:30 - 11:30 a.m. Eastern

Course Dates 

April 15, 2011

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471

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GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

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