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Session 2: FDA Plenary: PDUFA VII Information Technology and Bioinformatics
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
During this session presenters will cover a variety of topics from the PDUFA reauthorization performance goals and procedures fiscal years 2023 through 2027 goals letter section IV. Topics will include Digital Health Technology, Next Generation of the Electronic Submissions Gateway, Update on Expanding and Enhancing Bioinformatics Support and Data Standards Update.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the information technology and regulatory review perspectives of digital health technology
- Describe the detail that encompass the next generation of the electronic submissions gateway in the cloud
- Discuss the initiatives that focus on expanding and enhancing bioinformatics support
- List and explain selected key data standards initiatives in CDER and CBER
Speaker(s)
Update on Identification of Medicinal Products
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
Digital Health Technology: Regulatory Review Perspective
Andrew Potter, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Digital Health Technology: IT Perspective
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Update on Expanding and Enhancing Bioinformatics Support
Christopher Joneckis, PhD
FDA, United States
Associate Director for Review Management, CBER
Data Standards
Ray Wang, MBA, MS
FDA, United States
Director, Data Standards Staff, OSP, CDER
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