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 Understanding Compassionate Use Program Regulations in Latin America (LATAM)

10:00 am Morning Break & Networking

11:00 am Presented by Inceptua

11:30 am Navigating Operational & Regulatory Hurdles of South & East Asian Humanitarian Donation Programs

Compliant Transition of Patients to Commercial Programs

12:00 pm Presented by Bionical Emas

12:45 pm Lunch & Networking

1:45 pm Navigating Compliant Engagement & Effective Collaboration for a Successful Commercial Launch

2:15 pm Presented by myTomorrows

2:45 pm Evaluating the Shift to Named Patient & Paid-For Programs: Ethical & Practical Considerations

3:30 pm Afternoon Break & Networking

Use of Data Collection to Supplement Regulatory, Clinical Trial, & Therapeutic Development

3:45 pm Differentiated Approach to EAPs Using a Reimagined Model for Sourcing & Advancing Therapeutics

4:15 pm Success Stories of Data Collection in Compassionate Use Programs

4:45 pm Chairs Closing Remarks

4:50 pm End of Conference