Scilife Blog

TL;DR Most pharma AI pilots stall because they were designed to prove that a model works, rather than whether it can operate inside a regulated production environment. Common barriers include fragmented data, unclear ownership, late-stage validation ...

Keeping pace with regulatory change is becoming increasingly difficult for pharma, Medtech, and other life sciences organizations, as the pace and volume of regulatory changes has increased drastically over the past two decades.

Quick answer: What is ISO/IEC 42001? ISO/IEC 42001 is the first international standard for establishing and continually improving an AI management system. For life sciences organizations, it provides a structured way to govern AI risks, responsibilit...

The European Commission keeps a public repository of AI literacy practices. Real programmes from real organisations, published so you can copy what works. There are forty-odd entries, filterable by sector.

Quick answer The EU AI Act is the European Union's risk-based regulation for artificial intelligence. It applies to organizations that develop, provide or use AI systems, including pharmaceutical, biotechnology and medical device companies. Complianc...

Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk ...

From finding promising drug candidates to optimizing clinical trials and scaling up manufacturing, AI is reshaping the entire drug development journey, leading to faster development, lower costs, shorter timelines, and, most importantly, quicker acce...

The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices, and the regulatory landscape has moved fast to keep pace.

At the time of this updated blog post, regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are in place. Since 2023, the conversation has shifted decisively from "what should the rules for AI be?...

Key takeaways The FDA regulates AI-enabled medical devices through existing risk-based pathways, including 510(k), De Novo, and PMA. Final PCCP guidance allows planned device modifications without a new marketing submission for each change, provided ...