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Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS
Session Chair(s)
Betsy Fallen, RN
Consultant
BAFallen Consulting LLC, United States
Integrating Across Pharmaceutical Company CTMS Systems to Generate a Uniform Data Structure
Learning Objective : Define each technology and diffusion status; Describe efficiencies realized through each technology; Highlight success stories based on collaborative approaches to the development of standards; Identify the continued challenges regarding full integration for a seamless life cycle of essential inspection and regulatory documentation.
Speaker(s)
eTMF/EDM/eCTD: The Whole Shebang
Adair Turner, MSc, RAC
Cencora Pharmalex, United States
Sr. Director, Head of Regulatory Affairs US
The Complicated Life of a (TMF) eSubmission Document
Lisa Mulcahy
Mulcahy Consulting, LLC, United States
Owner, Principal Consultant
Integrating Across Pharmaceutical Company CTMS Systems to Generate a Uniform Data Structure
Graeme Benson, PhD
Drugdev.org, United Kingdom
Chief Information Officer
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