EPAI, The Ethics of Pharma AI, is a space to explore the ethical questions raised by the growing use of artificial intelligence in pharmaceuticals, particularly quality systems, GMP and manufacturing.
We are moving through a period of rapid technological change. Regulation and legislation often move more slowly, while discussions of AI still tend to emphasise technical possibilities and efficiency. We believe the ethical implications deserve closer attention.
We use this blog as a sketchpad of thoughts on AI and ethics in pharma, trying to spark some reflection rather than offer definitive answers.
What we explore
We look at how AI is being introduced into pharmaceutical quality systems, investigations, decision-making and manufacturing, and what that could mean for professional judgement, accountability, trust and patient protection.
Our central question is not simply whether AI can do something, but how far it should be relied upon, what we can reasonably demonstrate about its performance, and where human responsibility must remain.
Founded by Daniele Bassanese
EPAI was founded by Daniele Bassanese, a pharmacist and Qualified Person with experience in pharmaceutical quality, GMP and decisions concerning medicinal products.
We approach these discussions from a pharmaceutical quality perspective, with particular interest in how AI changes professional judgement, responsibility and the expectations placed on those working in regulated environments.
The articles are our own perspective, with the hope of sparking discussion and hearing different points of view. These articles are not regulatory guidance, nor do they represent the views of employers or authorities.
We try to understand what the regulations say, what they might mean in practice, and their possible implications when looked at from different, unusual and hopefully sometimes unique angles. Ultimately, these are just our own reflections and interpretations, shared to encourage discussion rather than provide definitive answers.
