Artificial Intelligence in Laboratories

This conference aims to address the impact of Artificial Intelligence (AI) on pharmaceutical laboratories and explore AI applications in analytical processes, regulatory compliance, and quality control.

Artificial Intelligence is transforming pharmaceutical laboratories by enhancing automation, data interpretation, and compliance monitoring. With the rise of machine learning, deep learning, and big data analytics, AI enables predictive analytics, anomaly detection, and process optimization, reducing human error and increasing efficiency. Regulatory authorities are increasingly focusing on these innovations to ensure AI implementation aligns with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines. This track will present case studies and discuss current trends, challenges, and opportunities for AI-driven laboratory operations.

This conference therefore deals with the following Topics:

• AI and GxPs
• Case Studies

Modern regenerative medicine systems such as cells and tissues or ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of medicinal products that is becoming increasingly important. With the entry into force of several regulatory directives, e.g. the European Directive EC 1394/2007 for ATMPs, such products have been classified as medicinal products and as such must comply with EU requirements for medicinal products. Although the biopharmaceutical industry has significantly intensified its activities in this area, many of these products are developed and manufactured at universities, hospitals and in small and medium-sized enterprises. These university or medical roots lead to special challenges for the respective institutions as well as for the regulatory authorities in meeting compliance requirements for quality, safety and GMP aspects and approval. The frequently given manufacturing conditions also contribute to this, e.g. the open manipulation of cells and tissues necessary for obtaining such products on a medical-surgical level, or the short shelf life of the obtained end product. And potentially there are always conflicts when it comes to the relevance of different guidelines, e.g. when an Annex 1, or an Annex 2 or a WHO Guideline does not harmonise with the ATMP Guideline. But also rapid tests and analyses are a challenge for such products with a short shelf life in terms of