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EMA Priority Medicines (PRIME)
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Expert InterviewJanuary 3, 2025
Ask the Expert: Mette Due Theilade Thomsen, Ph.D.
Sponsors often struggle with early PIP submissions for pediatric gene therapies due to their complexity. This article highlights EMA's guidance, the stepwise PIP pilot, and approaches to harmonize global pediatric plans for regulatory success.
Read: Ask the Expert: Mette Due Theilade Thomsen, Ph.D.Health AuthoritiesJune 18, 2025
Keeping Pace with Innovation: Current Insights from Global Health Authority Leadership
This week, we heard from health authority leaders from the United States, Europe, the United Kingdom, and beyond at the DIA 2025 Global Annual Meeting in Washington, DC, and one theme stood out: modernizing regulation to match innovation, with leading health agencies at the forefront.
Read: Keeping Pace with Innovation: Current Insights from Global Health Authority Leadership