Ensuring Compliance with ICH GCP E6 (R2) Requirements: Meeting the challenges of RBM 2017

Topics

• Explore the link in study level risk management and RBM
• Review of risk management principles
• Discuss the major changes to ICH GCPE6(R2)
• Review the changes in the regulatory environment
• Sharing best practice and cross-industry initiatives
• Discuss potential challenges and implementation of ICH GCPE6(R2)

Who should Attend

• Directors of Data Management
• Clinical Research Professionals
• Directors of Clinical Operations
• Clinical Data Management Professionals
• Project Managers
• Study Managers
• CRA`s
• Central Monitors
• IRB/IECs
• Project Management Statisticians
• Sponsor`s/CRO`s