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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 9 Track 3: Deciphering 10 Years of Regulatory and Business Documents to Confirm to Information Technology ETL Requirements

Session Chair(s)

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management

Merck & Co., Inc., United States

Innovation for producing medicines that transform patient’s lives is paramount to biotechnology companies. The challenge of how to bring this innovation mind-set to 10 years of regulatory documentation and registration data from multiple sources, has lived through numerous iterations of design with limited people resources. This cloud-based single source system of record with a single data model requires a new ELT and teamwork approach. This panel will discuss the technology, the partnerships, and the daily collaboration that allowed a multi-faceted group to quickly evolve into a team of innovators.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Integrate the multiple vendor and business relationships with an innovative mind-set into a unified data model
  • Discuss how an ELT technology can bring clarity to business decisions that affect documents, data, and drive solutions for uniformity
  • Recognize the future construct and need for savvy business administrators who will influence and perform IT related updates


Kelsey  Edwards, MS


Kelsey Edwards, MS

Vertex Pharmaceuticals Incorporated, United States

Manager, Regulatory Information Management

Juhi  Saxena, MSc


Juhi Saxena, MSc

Moderna, United States

Associate Director, Regulatory and Clinical Informatics Platforms

Murthy  Koppu, MS


Murthy Koppu, MS

fme US, LLC, United States

Principal Consultant

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