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Tuesday, June 18 • 8:00am - 9:00am
#208: Good Data Governance Practices: Regulatory and Industry Perspectives

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Kassa Ayalew, MD, MPH

Speaker

Update from the Danish Medicines Agency
Lisbeth Bregnhoj, PhD, MPharm

Update from Industry
Prasanna Rao

Update from the FDA
Cheryl Grandinetti, PharmD


Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
avatar for Lisbeth Bregnhoj

Lisbeth Bregnhoj

Medicines Inspector, GCP, Danish Medicines Agency (DKMA), Denmark
Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Prasanna Rao

Prasanna Rao

Global Head, Artificial Intelligence and Machine Learning, Pfizer Inc, United States
Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is the Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has over 25 years of experience in Information technology and Analytics, with 10 years in Healthcare... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session