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GCP and Inspection Readiness
Session Chair(s)
Marta Haley Fields, MBA
Senior Director, Research & Development Quality
Seattle Genetics, United States
A Comparison of FDA and EMA GCP Inspections
Learning Objective : Discuss how GCP inspections are performed by both the FDA and the EMA; Identify how to prepare both sites and sponsor to achieve an optimal outcome for the inspection.
Speaker(s)
A Comparison of FDA and EMA GCP Inspections
Marta Haley Fields, MBA
Seattle Genetics, United States
Senior Director, Research & Development Quality
PAI: Beginning with the End in Mind
Donna Dorozinsky, BSN, MSN
Just in Time GCP, United States
President & CEO
The Relentless Pursuit of ‘All Available Data’: Considerations for a European Pharmacovigilance Inspection
David Fryrear, MS
Astellas, United States
Executive Vice President and Head of Quality Assurance
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