PDA Southern California Chapter: Regulatory Landscape
Educational Sessions, Networking Opportunities, Exhibit Area
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Navigating the Evolving Regulatory Landscape
The regulatory environment for biopharmaceutical development and manufacturing continues to evolve rapidly, driven by new leadership priorities, legislative changes, advancing technologies, and increasing expectations for quality, data integrity, and supply chain resilience. Staying current with regulatory direction is essential for organizations seeking to maintain compliance while fostering innovation.
This PDA SoCal conference, taking place on February 19, 2026, at The Grand in Long Beach, will explore the current and emerging regulatory landscape, highlighting recent changes, enforcement trends, and anticipated shifts in regulatory expectations. Through expert perspectives and practical insights, the program will examine how evolving policies impact drug development, manufacturing, quality systems, and regulatory strategy, and how industry can proactively prepare for what lies ahead.
Katie’s Presentation Title: FDA Regulatory Landscape
Katie’s Presentation Summary: Katie will provide an update on the FDA changes from 2025 and what we are currently seeing at the start of 2026. She will give us insight on these FDA changes are impacting what we are currently seeing within the Regulatory Landscape.
Jingying Xu Presentation Title: FDA Regulatory Programs and Initiatives Related to Cell and Gene Therapy
Jingying Xu Presentation Summary: Jingying Xu talk focuses on how recent FDA programs and incentives shape drug development across the lifecycle, with particular relevance to cell and gene therapies. It briefly frames key initiatives in terms of their impact on clinical strategy and CMC, followed by a focused discussion on FDA’s approach to CMC flexibility and its implications for manufacturing, comparability, and licensure readiness
Highlighted Presenters
Key Presenters
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Katie Bevard
Eli Lilly and Company
Advisor - Quality, External Engagement and Advocacy/Global Quality Compliance
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Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
The Grand
4101 E Willow StLong Beach, CA 90815
Registration
Pricing Options
Standard Registration
Member Price
$30Non-Member
$60
Sponsors
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