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Session 7, Track 4: The Next Frontier in Regulatory Submissions: Powering Industry Growth with Structured Data to Deliver Value Through Connected Global Use Cases
Session Chair(s)
Cindy Chiu
Senior Director, Regulatory Affairs Operations
Merck & Co., Inc., United States
The session explores real-world examples of how structured data, GenAI, and semantic data standards can address regulatory challenges and prepare the industry for advanced submission strategies. Speakers will discuss advancements from regulators in digital and collaborative review initiatives and give insights on how the industry can prepare their data and processes to benefit from these advancements.
Key Players to Enable the Future of Regulatory Submissions - Katherine Novak, Epista Inc.
Future of Regulatory Submissions - Sridevi Nagarajan. DIA Communities Lead for AI in Healthcare
Advancing Regulatory Submissions with Standardized Semantic Structured Data - Heiner Oberkampf, ACCURIDS
Learning Objective : - Explain how structured data, GenAI, and semantic data standards can address regulatory challenges and prepare the industry for advanced digital submission strategies
- Examine the role of digital tools in the shift towards data-driven product authorizations
- Outline solutions to prepare structured data in order to benefit from global collaboration and cloud-based review to accelerate approval
Speaker(s)
Key Players to Enable the Future of Regulatory Submissions
Katherine Novak, MS
Epista Life Science, United States
Director
Future of Regulatory Submissions
Sridevi Nagarajan, PHD
Ayusarogya, United Kingdom
DIA Communities Chair for AI in Healthcare
Advancing Regulatory Submissions with Standardized Semantic Structured Data
Heiner Oberkampf, PHD
ACCURIDS, Germany
CEO
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