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Regulatory Strategy Considerations for Working with the FDA and EMA

Date: November 23, 10pm EST | November 24, 2pm AEST


  • Kimberly Cummings, Vice President, Regulatory Affairs
  • Maurice Bancsi, Director, Regulatory Affairs
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As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. The Food and Drug Administration (FDA) governs the drug and biologic approval process in the United States, while the European Medicines Agency (EMA) serves the European Union (EU) plus Iceland, Norway, and Liechtenstein.

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

  • How the FDA and EMA approach the new drug application process and meet with sponsors
  • Opportunities for expedited drug development through the breakthrough (US) and PRIME (European) designations
  • Significant differences in agency requirements for evaluating pediatric drugs