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Session 9 Track 3: Deciphering 10 Years of Regulatory and Business Documents to Confirm to Information Technology ETL Requirements
Session Chair(s)
Cindy Chiu
Senior Director, Regulatory Affairs Operations
Merck & Co., 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
Speaker(s)
Speaker
Kelsey Edwards, MS
Vertex Pharmaceuticals Incorporated, United States
Manager, Regulatory Information Management
Speaker
Juhi Saxena, MSc
Moderna, United States
Associate Director, Regulatory and Clinical Informatics Platforms
Speaker
Murthy Koppu, MS
fme US, LLC, United States
Principal Consultant