The Post-Marketing Authorization Elephant in the Room: Who Pays the Bill?
Friday, May 31, 2024 09:15 AM - 10:15 AM
Room 205-207
Regulation & Policy
Roundtable
Organized by: ISCT Committee on the Ethics of Cell & Gene Therapy (ECGT)
Moderator
Bridge regulatory and reimbursement requirements so market authorization does not become synonymous with withdrawn CGT products.
Key Learning Objectives
1. To identify all the steps to reimbursed patient access, beyond regulatory approval
2. To share experience and insight about what works well and pitfalls to avoid
3. To understand how generate evidence for regulatory and payer requirements to secure reimbursed patient access
Moderator
- John Rasko, Prof., Royal Prince Alfred Hospital, Australia
- Brad Groves, B. Arts(Hons), MAP Patient Access Limited, United Kingdom
- Tania Bubela, BSc (Hons), PhD, JD, FCAHS, FRSC, Simon Fraser University, Canada
- Samantha Pollard, PhD, Fraser Health, Canada
Bridge regulatory and reimbursement requirements so market authorization does not become synonymous with withdrawn CGT products.
Key Learning Objectives
1. To identify all the steps to reimbursed patient access, beyond regulatory approval
2. To share experience and insight about what works well and pitfalls to avoid
3. To understand how generate evidence for regulatory and payer requirements to secure reimbursed patient access
