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 Aligning Patient’s Needs with Commercial Goals: The Value of Collecting Real-World Data in EAPs Synopsis Download the Agenda for session details 9:30 am Advancing Safety in Managed Access Programs Synopsis Download the Agenda for session details 10:00 am Morning Break & Networking 11:00 am Roundtable Discussion: Rapid Response in an EAP: A Unique Challenge for Early Access Synopsis Download the Agenda for session details 11:30 am Navigating Operational & Regulatory Hurdles of South & East Asian Humanitarian Donation Programs Synopsis Download the Agenda for session details Enhancing Patient-Centricity in Programs & Compliant Transitions to Commercial Programs 12:00 pm Designing Patient-Centric Resources & Programs: Approaches for Supporting the Patient & Site Experience 12:30 pm Lunch & Networking 1:30 pm Navigating Compliant Engagement & Effective Collaboration for a Successful Commercial Launch Synopsis Download the Agenda for session details 2:00 pm Evaluating the Shift to Named Patient & Paid-For Programs: Ethical & Practical Considerations Synopsis Download the Agenda for session details 2:30 pm Afternoon Break & Networking Use of Data Collection to Supplement Regulatory, Clinical Trial, & Therapeutic Development 3:00 pm Differentiated Approach to EAPs Using a Reimagined Model for Sourcing & Advancing Therapeutics Synopsis Download the Agenda for session details 3:25 pm End of Conference 3:35 pm Chairs Closing Remarks DAY ONE FULL EVENT GUIDE
