Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace?

Last year, the EU did what the U.S. has not been able to do. The EU AI Act has brought unity to the various states in thinking and approach. The U.S. is still a bit more fragmented; however, the gaps are closing quickly. This is evident by the introduction of the California AI Accountability Act (California Senate Bill 896). This bill seems to be a natural piece of “child” legislation from the 2022 White House Blueprint for an AI Bill of Rights. Although this is not specific to the pharmaceutical industry, its applications are nonetheless impactful to it. When using mature “critical risk thinking” and incorporating this into a company’s three-year strategy, the impact becomes pressing to ensure that ethical adoption meets future expectations.

Accountability and oversight permeate most publications on this topic as standout themes. In my own conference presentations, an urgent emphasis has been made on transforming the capability in the quality function for AI and data skills. Now, with a new year underway, emphasis should be placed on risk management principles to incorporate a mitigation plan to address the present and future. The speed of adoption is unlike anything we have recently experienced. A key paradigm shift facing the industry is to change the narrative that the risk is not only “AI gone rogue,” but also leveraging the fact that AI (used responsibly) can have tremendous benefits to a firm.

The recently published FDA discussion paper “Artificial Intelligence in Drug Manufacturing” has outlined current Agency thinking as well as a call to action to industry for feedback. Additionally, a complementary read is a paper published by Ada Lovelace Institute (here) investigating the use of the FDA model of oversight in AI oversight. This document should give industry the confidence that there is a model to leverage that is not new, just in need of enhancement.

Lachman has incorporated these key learnings into our services and solutions. However, this is a journey for which a company should assess its readiness for a holistic change management program in not only its business plans, but QMS continuous improvement and Data Governance concepts. Global regulatory expectations are converging, but are you prepared for the journey? Reach out to us for a consult at