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Session 2 Track 1 - Organizational Transformation of Enterprise Systems and Standards
Session Chair(s)
Laura J. Sherman, MBA
Training Partner, Clinical Business Operations
Vertex Pharmaceuticals, Inc., United States
Learning Objective : 1) Utilize standardized taxonomy and metadata best practices to implement an integrated eDM/eTMF/eCTD solution in the cloud 2) Describe best practices for utilizing the eTMF and EDM reference model 3) Assess opportunities for information re-use
Speaker(s)
Demystifying eDMS, eTMF, and eCTD Integration
Adair Turner, MSc, RAC
Cencora Pharmalex, United States
Sr. Director, Head of Regulatory Affairs US
Pfizer Case Study: Organizational Transformation through Content Management Optimization - Business Aspects
Mary Emanoil, MS
Pfizer Inc, United States
Head, TMF & Registry Operations
Technical Aspects
David Andrew Clark
Pfizer, United States
Solution Engineer
Smarter Information Management
Michael Rosenblatt
Roche, United States
Global Head, Regulatory Technology Solutions
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