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Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Session Chair(s)
Mandy Kaur Budwal-Jagait, MSc
Head of GCP
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies
Learning Objective : Describe the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.
Speaker(s)
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Adil Nashed
Health Canada, Canada
Compliance Specialist, Clinical Trial Compliance Program
Panelist
Peter Twomey, MA, MPharm
European Medicines Agency, Netherlands
Head of Inspections
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Kavita C. Dada, PharmD, RAC
FDA, United States
Associate Director for Regulatory Operations, OSI, OC, CDER
Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Reina Hayashi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
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