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Session 7: Track 2: Digital Disruption Across Regulatory Affairs
Session Chair(s)
Jake Doran
Head of Digital
Lykos Therapeutics, United States
Technology advancements in the regulatory space have long been stifled due to the need to adhere to multiple and sometimes conflicting requirements. As a result, regulatory organizations of today are often unable to keep up with the technology solutions being applied across the drug development spectrum, in other areas such as clinical, safety, or manufacturing. In this session, we will share how digital disruption can be approached within regulatory, how to identify opportunities, develop strategies for ensuring the digital investment is fully realized (in quality, efficiency, and enhanced compliance), and provide examples on building the broader business case to support such investments.
Learning Objective : - Understand how emerging technologies can be applied across standard regulatory technology environments to drive user adoption, enhance data quality, and ensure compliance
- Identify areas of opportunity where emerging technologies can be applied to common regulatory processes
- Demonstrate how organizations can ensure significant ROI when investing and implementing foundational regulatory technology solutions by complimenting these solutions with digital
Speaker(s)
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Armen Kherlopian, PhD
Genpact, United States
Chief Science Officer