Agenda

 

Why Attend?

Regulatory agencies conduct Good Clinical Practice (GCP) inspections to verify the reliability of data generated in clinical trials and adequacy of human subject protection, in addition to ensuring that clinical trials are conducted according to the applicable regulations. In this era of globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct to optimize regulatory resources and oversight.

This workshop will provide US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Medicines and Healthcare products Regulatory Agency UK (MHRA) perspectives on the importance of quality management practices on data reliability. It will provide regulatory perspectives on data management, data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials. The workshop participants will have opportunities to work on relevant case studies on these topics.

Workshop Objectives:

At this event, participants will learn:

• Regulatory perspectives on importance of quality management systems on data reliability
• How data management practices may impact data reliability
• Impact of data blinding on data reliability
• How audit trails may be used to assess data integrity
• How to evaluate data integrity/reliability using case examples

Who Should Attend?

• Clinical Quality Assurance Professionals
• Clinical Operations Professionals
• Data Management Professionals
• Clinical Trial Electronic Systems Developers
• Clinical Trial Statisticians and Statistical Programmers
• Clinical Investigators and Clinical Investigator Site Staff
• Regulators- GCP inspectors
• Regulators- Reviewers/Assessors of Clinical Trial Data 

FDA & MHRA Resources