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 Malia is Director, Development Records Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.