Overcoming Regulatory & Operational Challenges within APAC to Geographically Extend Patient Reach
Time: 2:00 pm
day: Pre-Conference Workshop Day
Details:
Biopharma companies often hope to offer pre-approval access to patients outside of the US, but certain regions, particularly Asia-Pacific (APAC), present complex regulatory and operational challenges that can hinder this effort. This workshop will highlight these challenges and address what solutions may exist to help demystify pre-approval access in these markets to help in ethically expanding the global footprint of preapproval access.
Key Takeaways:
- Gain insights into the nuances in regulatory pathways and import regulations, as well as program design and opportunities in countries such as Japan, China and South Korea
- Understand the need for distributors and vendors in these programs, to ensure compliant operation and accelerated drug delivery to patients
- Lessons learned from recent examples of expanded access implementation in the APAC region
