3-hr Virtual Seminar: Annual ICH GCP Refresher Course 2013

Key Topics

• Coverage of ICH requirements for the Investigator
• Background information on the need for standardized GCP guidelines for the clinical research industry
• Coverage of ICH requirements for IRBs
• Coverage of ICH requirements for the Sponsor
• Adverse Event and Serious Adverse Event reporting
• Subject rights
• Document retention requirements
• Essential document requirements
• Best practices and fraud

Who should Attend

Personnel from companies in the clinical research industry, including:

• Research Nurses
• Principal Investigators
• Site Regulatory Personnel
• Study Coordinators
• Sponsor site selection personnel
• Clinical Research Site Administrators
• Quality Assurance
• CRAs
• Healthcare professionals
• Documentation professionals both at the site and sponsor companies