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Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective
Session Chair(s)
Mandy Kaur Budwal-Jagait, MSc
Head of GCP
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
This session covers the importance of the trial risk assessment process, change control implementation and presents case studies from multiple regulators where effective RBQM could have helped prevent significant GCP non compliances for eSystems/DHTs
Learning Objective : Discuss QbD and critical to quality factors for data reliability and participant safety in clinical trials including requirements in ICH E6 R3; Understand the importance of change control and risk assessment for data governance and eSystems/ DHTs; Learn from regulatory inspection and compliance case studies from multiple regulators; Identify routine GCP inspection requests.
Speaker(s)
Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Representative Invited
FDA, United States
Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Representative Invited
Health Canada, Canada
Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Representative Invited
European Medicines Agency, Netherlands
Alphabet Soup: Utilisation of QbD and RBQM in Clinical Trials Data Governance – A Multi-Regulator Inspection Perspective
Representative Invited
Pharmaceuticals and Medical Devices Agency, Japan
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