Ana Hidalgo-Simon – Head of Advanced Therapies, European Medicines Agency (EMA)

Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.  
[Advanced] therapies are complex, difficult, and have a huge public health impact, which means that the development and approval process is long and challenging
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