Joanne Malia is Director, Clinical Documentation 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 as co-lead of the Change Control Board for the TMF Reference Model group, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.