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Tuesday, June 27 • 10:30am - 11:30am
The Future of Regulatory Submissions: Opportunities and Challenges

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Component Type: Forum
Level: Intermediate

This forum will include a discussion on opportunities and challenges for future regulatory submissions and share knowledge and provide views to help overcome challenges in the areas of policy, technology, standards, data sovereignty and security, and records management. Panelists will include representatives from health authorities, industry, and non-profit organizations.

Learning Objectives

Describe the current regulatory submission mechanism; Explore opportunities for the future regulatory submission and data exchange, data sharing paradigm; Discuss challenges to implement changes from policy, technology, standard, data sovereignty and security, records management perspectives.

Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
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