Archives: Agenda

• Understanding the current FDA regulatory landscape and its impact on rare diseases clinical development
• Identifying common regulatory pitfalls that delay approvals and strategies to mitigate them early
• Exploring innovative trial design that shorten timelines whilst keeping compliant with changing regulation

Moderator:

Panel seat reserved for event sponsor

🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

• How to transition from paper to digital labeling efficiently without doubling workload or creating parallel processes
• How to navigate regional eLabeling requirements and implement solutions that fit small internal teams
• How to maintain inspection readiness with hybrid (paper + digital) labeling while staying compliant

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• How to make sure you are building accountability and reconciliation practices into the study planning up front, before the first shipment is dispatched
• How to clearly define the accountability process and primary system of record to ensure sites and CROs understand expectations for documentation, reconciliation and destruction
• How to standardize site-level data capture while accommodating local practices to prevent mismatches and delays at study closeout
• How to leverage electronic systems to embed audit-ready accountability into daily workflows, shifting from reactive clean-up to real-time documentation
• How to ensure a controlled IRT closure that eliminates discrepancies and supports complete, audit-ready records that helps you to save money in the long run

• Hear directly from a venture capitalist on what investors look for in California biotech startups
• Learn strategies to secure funding and build compelling value propositions
• Understand how to navigate a competitive biotech investment landscape

• What is really stopping us today: Lack of internal training, Limited digital integration, Scalability pressures, Other operational or regulatory barriers. What next practical steps can we take to overcome these hurdles?
• Live polls or short Q&A to capture attendee perspectives