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

9:00 am Roundtable Discussion: Navigating Europe’s Regulatory Landscape for Compassionate Use Programs

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

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

1:45 pm Evaluating the Shift to Named Patient & Paid-For Programs: Ethical & Practical Considerations

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

3:15 pm Chairs Closing Remarks

3:25 pm End of Conference