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Monday June 15, 2026 1:05pm - 1:35pm EDT
Component Type: Session

Explore how AI enabled authoring is transforming regulatory content development, delivering measurable improvements in speed, consistency, and quality across submissions. Discuss how process standardization serves as the critical enabler for automation, supporting faster, more scalable submission execution. Understand how connecting authoring, standardization, and automation enables regulatory intelligence, unlocking insights from submission content to support proactive planning and decision making.

Learning Objectives

Explain how AI-enabled authoring, process standardization, and automation connect to create a modern regulatory submission ecosystem; Demonstrate practical steps and frameworks organizations can use to implement across the regulatory ecosystem; Discuss how integrated submission processes generate regulatory intelligence that supports proactive decision making.

Chair

Parexel

Speaker

Speaker
Katie Connelly


Speakers
avatar for Katie Connelly

Katie Connelly

SVP, Global Head of Regulatory Affairs, Parexel International, United States
Katie, a senior leader at Parexel, brings extensive experience in designing, implementing, and delivering regulatory programs, with deep expertise in product leadership and change management. She oversees global regulatory affairs and operations outsourcing, regulatory FSP, submissions... Read More →
avatar for Parexel

Parexel

United States
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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