Navigating the Regulatory Landscape for Glioblastoma: Discussing Insights into Successful Strategies for Gaining Approval in Challenging & Complex Disease Spaces such as GBM
Time: 8:30 am
day: Workshops A & B
Details:
- Hurdles in gaining approval: Discuss difficulties in regulatory approval for GBM therapies due to the complexity of the disease
- Navigating the regulatory process: Highlighting effective approaches for navigating the regulatory process in GBM, including clinical trial design and data requirements
- Explore the role of collaboration: Highlighting the importance of relationships between biotech companies, regulatory agencies, and researchers in streamlining approval processes
- Successful FDA approval: Discussing appropriate processes for coming out of phase 3 clinical trials
