#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm
Sarah Ann Silvers, MS
- Director, GCP Process Control and Compliance
- Ce3, United States
As Director, GCP Process Control & Compliance, Sarah oversees Ce3’s Clinical Quality Program- leading and conducting domestic and international audits (internal, sponsor, investigator, CRO, vendor, and TMF audits), writing procedure, educating staff and implementing regulation and guidance, inspection readiness, etc. Sarah is also a highly-regarded instructor in GCP. Sarah earned a MS in Regulatory Science and is a registered Quality Assurance Professional in GCP (Society of Quality Assurance).
Joanne S. Malia
- Associate Director, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity she interacts with internal senior level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Regeneron business practices and clinical research program objectives.