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GCP/ICH Obligations of Sponsors, Monitors, and Investigators: How to guarantee a clean inspection/audit

 
  October 23, 2013  
     
 
Global Compliance Trainings, online
2013-11-14


Well-controlled and well-conducted clinical trials are important to both sponsors and investigator sites. Compliance with Good Clinical Practice and ICH guidelines will ensure quality data, speeds up the review process for new drugs and decreases the costs to sponsors. This webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections

 
 
Organized by: Global Compliance Trainings
Invited Speakers: Charles H. Pierce
 
Deadline for Abstracts: 2013-11-13
 
Registration: 2013-10-23
E-mail: globalcompliancetrainings1@gmail.com
 
   
 
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