SESSION V – PRODUCTION
AI and new technologies supporting Pharma manufacturing
SALA DEL TEMPIO
09:00-13:00

The session will begin with two presentations by the Sustainability GDS, which intends to present an analysis of the update to the European Sustainability Reporting Standards (ESRS) at the AFI 2026 Symposium. The ESRS constitute the mandatory and voluntary regulatory framework that defines how companies subject to the Corporate Social Responsibility Directive (CSRD) must prepare and communicate their sustainability reporting. The presentation will discuss sustainable investments for reducing economic and environmental risks and their relationship with reporting requirements. Subsequent presentations will provide an update on the progress of the pilot phase of Italian serialization from a production perspective. The topic was discussed with De Luca, who will give a complementary presentation on distribution issues for the Supply Chain Session. We will then invite the GMP Med Office to speak primarily about the revision of the regulations on changes to workshops, leaving them the opportunity to make any other communications they deem useful and important. In the second part, we will address the topic of innovation and AI, starting with a presentation on the modular factory approach, which is proving particularly beneficial in Germany, with a presentation by Mr. Banti of ANIPLA.

This will be followed by three presentations focusing on the application of AI. The first will illustrate the digital twins approach to optimizing pharmaceutical production, the second with a presentation in which AI allows the optimization of an important process such as the spotting of injectables, and finally with the presentation of an application in maintenance, active at Zambon, which helps to choose interventions and their frequency based on objective criteria.