Regulatory Strategy Considerations for Working with the FDA and EMA

October 4th, 2022
9:00 a.m. EDT
| 6:30 p.m. IST

This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more.

We’ll discuss:

  • 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

Presented By:

Kimberly Cummings, Vice President, Regulatory Affairs

Maurice Bancsi, Director, Regulatory Affairs