Training: AI and ML in the life-cycle of medicinal products

In response to the rapid evolution of artificial intelligence (AI) in the life cycle of medicines, EMA has published several documents that illustrate the current situation regarding the role of AI in the development, regulation and safe and effective use of medicines.

Based on the documentation developed by EMA, Maxer has created a training programme dedicated to pharmaceutical companies that delves into the use of AI and Machine Learning (ML) systems in the life cycle of medicinal products.

In particular, the course focuses on using AI and ML systems that, characterized by huge numbers of parameters configured in a non-transparent architectural model, generate new risks that must be mitigated to ensure patient safety and the integrity of clinical data.

Among the topics covered, it is appropriate to highlight some considerations of general interest regarding regulatory requirements, ethical aspects, risks of prejudice and other forms of discrimination potentially inherent in the training procedures of AI / ML systems.