SESSION X - PHARMACEUTICAL RAW MATERIALS
APIs: technological developments and regulatory updates
SALA DEL CASTELLO 1
15:15-18:00

The Raw Materials Session will be divided into two parts. The first part will illustrate regulatory developments at European level aimed at reducing the risk of API shortages on the global market, which have a significant impact on European API manufacturers. This overview will be accompanied by a presentation that we have requested from AIFA to provide us with an update on regulatory developments in the API sector. The second part of the session will be dedicated to presenting some technological aspects of API manufacturing, with particular reference to the management of Annex 1 requirements for API production and the results of applying AI in the critical stages of a production process.