Interview with EMA Head of Advanced Therapies Ana Hidalgo-Simon

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EMA Head of Advanced Therapies Ana Hidalgo-Simon

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MA’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.

Q: Although the European Medicines Agency (EMA) has been assessing and approving advanced therapies for over a decade, the Committee for Advanced Therapies is about to celebrate only its second birthday. How is the office structured today and what actions have been undertaken to ensure it is fit for purpose?

A: EMA’s Committee for Advanced Therapies (CAT) has been in place for over 12 years, but the creation of the Advanced Therapies Division in April 2020 gave a clearer external signal of our commitment to advanced therapies. There is no single unified way of working in such a complex field, so a matrix organisation with very strong coordination has always been key; the fact that the office appeared on the EMA organigram two years ago is just part of a normal evolution in the support provided.

Read the full interview on PharmaBoardroom.

Republished with permission.

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