How Many Alexes Does It Take To Launch A Drug w/ Daphne Smyth
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Europe looks like one market on a map, but try bringing a drug across borders and you quickly learn it behaves like many systems at once. We sit down with Daphne Smyth, a regulatory leader based in Ireland with 35+ years in pharmaceutical regulatory affairs, to unpack a mistake we keep seeing: companies build commercial teams first, then discover they have not built the regulatory pathway needed to launch at all. The result is not just delay, it is avoidable rework in clinical plans, manufacturing set-up, and the evidence story regulators expect.
We spend a big part of the…
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