Panel Discussion: Harmonising European Regulations & Approaches to Compassionate Use Programs
Time: 9:45 am
day: Conference Day One
Details:
- Providing an overview of alternative Pre-Approval Access pathways in Europe
- Exploring the potential for harmonizing rules across European countries and compare company practices and requirements in managing access
- Comparing the different requirements/criteria of individual patient programs versus larger group programs and the use of commercial material from different countries
- Analysing the challenges of cross-indication and off-label approval
