Roundtable Discussion with Key Stakeholders: Inspection Excellence - Sponsors, Sites, and Vendors share lessons with each other
Thursday, May 18, 2023, 1:00 PM - 1:50 PM
Regulatory agency inspections touch all organizations in the clinical trial ecosystem, but sometimes the stakeholders don’t exchange lessons and insights that could benefit each other, build collective wisdom, and create better inspection experiences and outcomes.
This panel will offer important lessons they’ve learned independently, and how sharing information with other participants in clinical research can contribute to inspection success.
• Roberta Ferreira - Executive Director – QA Regulatory Inspections and Client Audits, PPD
• Karen Harvey - Senior Director, Avoca Quality Consortium, Avoca, A WCG Company (Facilitator)
• Melissa Holbrook, MSN, NP - Executive Vice President, Operations, Velocity Clinical Research
• Mary MacDonald, MS, RQAP-GCP - Head of Clinical Quality Assurance, Neuroscience, Takeda Pharmaceuticals
• Jordan McKenzie, RN, BSN, CCRP - Director, Clinical Quality, Curebase
• Kate Sasamoto, JD - Director of the Office of Compliance Review, University of Michigan
• Karen Harvey - Senior Director, Avoca Quality Consortium, Avoca, A WCG Company (Facilitator)
• Melissa Holbrook, MSN, NP - Executive Vice President, Operations, Velocity Clinical Research
• Mary MacDonald, MS, RQAP-GCP - Head of Clinical Quality Assurance, Neuroscience, Takeda Pharmaceuticals
• Jordan McKenzie, RN, BSN, CCRP - Director, Clinical Quality, Curebase
• Kate Sasamoto, JD - Director of the Office of Compliance Review, University of Michigan