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DTSTART;VALUE=DATE:20260302
DTEND;VALUE=DATE:20260304
DTSTAMP:20260416T153721
CREATED:20251121T115047Z
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UID:9559-1772409600-1772582399@thebiocalendar.com
SUMMARY:BIO Investment and Growth Summit
DESCRIPTION:This premier conference brings together newly public and select private biotech companies with the investment banking community for two days of business and regulatory sessions\, Company Presentations\, BIO Partnering™\, and networking. \nJoin us in Miami Beach for two impactful days as we address the most pressing issues facing our industry\, from navigating the financial landscape for life sciences to tackling the ever-changing regulatory and policy challenges that affect biotech companies of all sizes. You’ll also have the opportunity to build relationships with strategic partners for investment and receive guidance on capital formation\, commercialization\, reimbursement\, and growth.
URL:https://thebiocalendar.com/event/bio-investment-and-growth-summit/
LOCATION:Miami Beach\, Miami Beach\, FL\, 33139\, United States
CATEGORIES:Investor,Networking
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DTSTART;TZID=America/Los_Angeles:20260303T110000
DTEND;TZID=America/Los_Angeles:20260303T120000
DTSTAMP:20260416T153721
CREATED:20260129T145423Z
LAST-MODIFIED:20260205T132200Z
UID:9834-1772535600-1772539200@thebiocalendar.com
SUMMARY:The Future of CGT Manufacturing Panel Discussion: Integrating Digital Solutions With Regulatory Readiness
DESCRIPTION:Transform your CGT manufacturing from a regulatory bottleneck into a competitive powerhouse. Learn how digital integration slashes release times and harmonizes FDA/EMA compliance. You’ll walk away with a clear roadmap for scaling “batch-of-one” production using real-time analytics\, ensuring your operations are both future-proof and ready for global commercialization.
URL:https://thebiocalendar.com/event/the-future-of-cgt-manufacturing-panel-discussion-integrating-digital-solutions-with-regulatory-readiness/
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CREATED:20260205T142903Z
LAST-MODIFIED:20260205T142903Z
UID:9851-1772535600-1772539200@thebiocalendar.com
SUMMARY:Where Biologic Stability Programs Fail—and How ICH Q1 Can Help You Get It Right (Free Webinar)
DESCRIPTION:The draft ICH Q1 guidance marks a major shift in biologics stability\, turning it from a back-end regulatory task into a front-line\, risk-based development discipline. This session explores why traditional approaches fall short\, where hidden risks emerge late\, and how ICH Q1 can be applied to strengthen programs across the product lifecycle. \nYou’ll learn how to:\n– Identify common stability program failures that surface during INDs\, comparability\, and scale-up\n– Apply ICH Q1 principles to real-world storage\, excursion studies\, and forced degradation\n– Reduce late-stage regulatory\, analytical\, and supply-chain risk\n– Build stability strategies that support confident IND\, BLA\, and commercial execution
URL:https://thebiocalendar.com/event/where-biologic-stability-programs-fail-and-how-ich-q1-can-help-you-get-it-right-free-webinar/
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DTSTART;TZID=America/Los_Angeles:20260303T110000
DTEND;TZID=America/Los_Angeles:20260303T120000
DTSTAMP:20260416T153721
CREATED:20260205T185723Z
LAST-MODIFIED:20260205T185723Z
UID:9855-1772535600-1772539200@thebiocalendar.com
SUMMARY:The Future of CGT Manufacturing Panel Discussion: Integrating Digital Solutions With Regulatory Readiness
DESCRIPTION:Cell and gene therapy manufacturing is evolving fast—and scaling successfully now requires more than just meeting regulatory expectations. It requires turning them into an advantage. \nOur Panel will explore how leading CGT manufacturers are navigating cGMP complexity\, harmonizing FDA and EMA requirements\, and using digital tools to embed quality at the source—while scaling from batch-of-one to commercial production. The panel will also share practical guidance on building a paperless foundation\, accelerating release times\, and preparing for what digitally mature CGT operations will look like over the next five years. \nIf you’re involved in CGT manufacturing\, quality\, regulatory\, or digital transformation\, this is the event for you.
URL:https://thebiocalendar.com/event/the-future-of-cgt-manufacturing-panel-discussion-integrating-digital-solutions-with-regulatory-readiness-2/
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