November 24th, 2022
2:00 p.m. AEST
This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more.
- How the FDA and EMA approach the new the drug application process and meet with sponsors
- Opportunities for expedited drug development through the breakthrough (U.S.) and PRIME (European) designations
- Significant differences in agency requirements for evaluating pediatric drugs
Kimberly Cummings, Vice President, Regulatory Affairs
Maurice Bancsi, Director, Regulatory Affairs