Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment
Betsy Fallen, RN
- BAFallen Consulting LLC, United States
Betsy is an expert on business processes and technology. After 25 years at Merck & Co., as an independent contractor, she now supports sponsors, vendors and clinical sites in their innovation journey while ensuring compliance. Trained as an RN, she is dedicated to ensuring the patients experience is considered as the drug development process continues towards innovation.
Daniel F. Orfe, MS
- President and CEO
- Regulatory eSubmissions, LLC, United States
Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).