Conference Day Two Thursday, March 20, 2025 7:45 am Coffee & Registration 8:20 am Opening Remarks Turbocharging Understanding of Global Regulatory Considerations to Ensure Compliant Program Planning & Execution 8:30 am Fire-Side Discussion: Increasing Efficiency & Streamlining Global Regulatory Landscapes Synopsis Download the Agenda for session details 9:00 am Roundtable Discussion: Navigating Europe’s Regulatory Landscape for Compassionate Use Programs Synopsis Download the Agenda for session details 9:30 am Morning Break & Networking 10:30 am Presented by Inceptua 11:00 am Navigating Operational & Regulatory Hurdles of South & East Asian Humanitarian Donation Programs Synopsis Download the Agenda for session details Compliant Transition of Patients to Commercial Programs 11:30 am Presented by Bionical Emas 12:15 pm Lunch & Networking 1:15 pm Navigating Compliant Engagement & Effective Collaboration for a Successful Commercial Launch Synopsis Download the Agenda for session details 1:45 pm Evaluating the Shift to Named Patient & Paid-For Programs: Ethical & Practical Considerations Synopsis Download the Agenda for session details 2:15 pm Afternoon Break & Networking Use of Data Collection to Supplement Regulatory, Clinical Trial, & Therapeutic Development 2:45 pm Differentiated Approach to EAPs Using a Reimagined Model for Sourcing & Advancing Therapeutics Synopsis Download the Agenda for session details 3:15 pm Chairs Closing Remarks 3:25 pm End of Conference DAY ONE FULL EVENT GUIDE