The advent of digital technologies like artificial intelligence and machine learning (AI/ML) to manufacture and control pharmaceutical products has occurred.  Examples presented at ISPE meetings and workshops in 2023 and 2024 demonstrate the technologies’ potential to fully automate pharmaceutical manufacturing. However, the full potential will only be realized once these digital technologies are reliably implemented at scale so that the promise of Pharma 4.0 is realized for manufacture of products globally. 

In order to progress on the journey, the event foresess 4 sessions with use-case discussed in small groups together with Health Authority representatives.