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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 4 Track 3 - Technology Enablers to Optimize EDM

Session Chair(s)

Michelle L. Charles, MPH

Michelle L. Charles, MPH

Director, Regulatory Affairs, Gene Therapy Program

University of Pennsylvania, Perelman School of Medicine, United States

Advances in technology have enabled the industry to continuously innovate in the creation, management, and integrity of data and documents. This session will present a variety of technology developments and offer the impact and benefit of each advance. Beginning with electronic and digital signatures incorporated into document approvals and workflows, the session builds with sharing the advances needed to enable the collaborative processes between consortiums, business partners, and sponsors with disparate systems. The final presentation will bring it all together with an overview on the impact and benefit of the adoption of an eTMF on a Clinical Data Management group. Get insight on how implementing cutting edge technology along with adopting efficient technology enablers into business processes can to lead to improved resource utilization, efficient business processes, enhanced integrity, and compliance.

Learning Objective : Describe eTMF (electronic Trial Master File) implementation within major Pharma Company Clinical Data Management. Discuss Best Practices, usage of eTMF reference model, tool used and limitations encountered, Global implementation considerations. Highlight Efficiencies gained, business process development considerations. Ultimate vision of the project from business perspective.


Ellen  Reilly, MBA

Managing Trust, Identity, and Security in Digital Transactions

Ellen Reilly, MBA

DocuSign, United States

Vice President

Elisa  Cascade, MBA

Facilitating Collaborations Through Technology

Elisa Cascade, MBA

Advarra, United States

Chief Product Officer

Ajitha  Gadangi, MS

eTMF for Clinical Data Management

Ajitha Gadangi, MS

Merck & Co., Inc., United States

Associate Director

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