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Nithiya Ananthakrishnan
Senior Vice President, Biometrics - Executive Leadership - Clinical Solutions
(SizeLimitingPyList: [linkedin]) -
Amanda Knapp
Director, Business Development -Clinical Solutions
(SizeLimitingPyList: [linkedin]) -
Colin Dailey
Director, Business Development - Clinical Solutions
(SizeLimitingPyList: [linkedin])
Speaker Session
The Oversight Gap: How Emerging Biotech Can Meet ICH E6(R3) Expectations Without Buildings Large Scale Teams?
Speaker: Nithiya Ananthakrishnan, Senior Vice President, Biometrics and FSP Sservices
Wednesday, October 7, 2026 | 01:45 PM - 02:45 PM
This panel will cover the following topics:
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Understand how ICH E6(R3) changes expectations for sponsor oversight and accountability.
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Identify common oversight gaps within lean biotech operating models.
- Explore practical approaches to risk-based oversight, co-monitoring, and quality management.
- Learn how to create scalable oversight capabilities without significantly expanding fixed infrastructure.
- Gain actionable ideas to improve inspection readiness and trial quality outcomes.
