Regulatory Considerations for Working with the FDA vs. the EMA

Presented by

Premier Consulting – Kimberly Cummings, Vice President, Regulatory Affairs, & Maurice Bancsi, Director, Regulatory Affairs

About this talk

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 (U.S.) and PRIME (European) designations – Significant differences in agency requirements for evaluating pediatric drugs Questions? Contact info@premier-research.com

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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.