Europe's sterile manufacturing sector has moved past Annex 1 preparation into the harder reality of execution: redesigning contamination strategies after real inspection findings, deploying robotics on live fill-finish lines, and delivering the largest wave of sterile facility investment in a generation — Lilly Alzey and Novo Nordisk Kalundborg among them. This Summit is the European meeting point for the directors who run sterile operations and the engineers who build the facilities. Two days, single track, closed-door — built around what is actually happening on the floor, in the cleanroom, and on the project site, not what the regulation says on paper.