The concepts of Speak Up and Quality Culture have received renewed attention with recent developments of the European Union’s Artificial Intelligence Act. Lachman recently blogged about the importance of a healthy quality culture (Speak Up! Does Your Quality Culture Have a Voice?), and new proposals under the Digital Omnibus package in the EU introduce three […]
Pharmaceutical Technology has featured Charlie Gibbons, Director of Compliance at Lachman Consultants in an article, AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights, following his recent presentation at the PDA Global Regulatory Conference. In his session at the conference, Charlie provided valuable insights into today’s evolving regulatory landscape, highlighting the practical […]
The AI Action Plan was initiated by Executive Order (EO) 14179, signed in January 2025, which directed the federal government to remove barriers to AI innovation and develop a national strategy. Following a public consultation that generated over 10,000 comments, the plan was released in July 2025 with input from industry, academia, and government stakeholders. […]
Artificial intelligence is advancing at an unprecedented speed, with breakthroughs happening almost daily. One of the most fascinating—and potentially unsettling—developments is the idea that AI systems could replicate themselves. Picture an AI model so advanced that it can create a duplicate of its own functionality. What once sounded like pure science fiction is now inching […]
In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]
When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities? Even when outsourced, the contract giver needs to have the requisite skills to provide adequate oversight. These concepts are also summarized in the FDA publication “Q10 Pharmaceutical Quality System” regarding both […]
Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]
The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]
Protecting us from our own technology has never been easy. On December 8, 2023, the EU reached a milestone to help us do just that, by reaching a provisional agreement on the first dedicated law on the use of artificial intelligence (AI). This breakthrough legislation is one of the first comprehensive attempts globally to regulate […]
The artificial intelligence paradigm shift is taking what was once a wish into reality, specifically, cross-regulatory agency coordination and harmonization. The latest publication in this area is a joint effort of the U.S. Food and Drug Administration (FDA), U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada to define guiding principles in AI […]
