Back to Agenda
Good Data Governance Practices: Regulatory and Industry Perspectives
Session Chair(s)
Kassa Ayalew, MD, MPH
Director, DCCE, OSI, Office of Compliance, CDER
FDA, United States
In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.
Learning Objective : Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.
Speaker(s)
Update from the Danish Medicines Agency
Lisbeth Bregnhøj, PHD, MPHARM
The Danish Medicines Agency, Denmark
EC ICH E6(R3) Expert Working Group Member
Update from Industry
Prasanna Rao
Saama, United States
Chief Products and Innovation Officer
Update from the FDA
Cheryl Grandinetti
FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
Have an account?