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Session 5 Track B: GCP Inspections: An Abbvie Case Study
Session Chair(s)
Judith Mergl, MSC
Head of Regulatory Affairs and Operational Services, Canada
AbbVie Corporation, Canada
Consistent with other jurisdictions, Health Canada inspects approximately 2% of all clinical trial sites in Canada on a yearly basis. The mandate of these onsite clinical trial site inspections ensures participants in clinical trials are not subjected to undue risks, data is generated appropriately per GCPs, appropriate complaints investigations, and compliance with Division 5 of the Food and Drug Regulations - Drugs for Clinical Trials. This session will highlight the differences between Clinical Trial site GCP and Clinical Trial Compliance Sponsors audits.
Learning Objective : At the conclusion of this session, participants should be able to:
- Distinguish between clinical trial site GCP audits and Sponsor CTC (Clinical Trial Compliance) inspections
- Gain and apply key learnings and insights from recent CTC inspections
Speaker(s)
Insights from a Regulatory Monitoring Perspective
Amber McLeod, PHD
Abbvie Corporation, Canada
Immunology, Virology, and Specialty Head, Regulatory Affairs
Insights from a Clinical Site Management and Monitoring Perspective
Reena Gill, MPH
AbbVie Corporation, Canada
Senior Clinical Operations Manager