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Whether you are in a big pharma company, an emerging biotech, or a CRO, the reality is the same: we all rely on vendors. But simply hiring a vendor and hoping for the best doesn’t cut it anymore. Today, having a rock-solid oversight process and governance model isn’t just “nice to have” - it is survival. You might be asking, “Why the sudden urgency?” The short answer is that the regulators have drawn a line in the sand....

For a significant part of my career, I thrived as an Individual Contributor. I had the opportunity to lead projects, make technical decisions, and managed project teams, but I eventually realized that managing a project is vastly different from leading people. Growing up, I was fortunate to be surrounded by exceptional leaders. Speaking with them didn’’’t just inform me; it inspired me. I aspired to be transformational, someone who motivates people to achieve both personal and organizational heights rather than a transactional manager who simply tracks tasks and manages output....

In my previous post, I explored the European Commission guidelines and the EU AI Act, looking at how they influence AI applications and the validation strategies surrounding them. This time, I want to shift focus to the FDA’s draft guidance on AI, released in January 2025. Although still in draft form, the document is an important signal of how the FDA is approaching AI, and it helps us understand what kinds of validation methodologies are expected to align with global regulatory thinking....

In my previous post, I explored how AI is transforming pharmacovigilance and highlighted use cases that go beyond case intake. Building on that discussion, I wanted to understand how organizations are validating AI applications and what regulatory guidelines say about it. While numerous frameworks exist-issued by bodies such as the FDA, WHO, CIOMS Working Groups, EMA, and Health Canada-I focused my review on two key documents: The EU AI Act EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (draft) These are highly relevant to pharmacovigilance systems and encapsulate most of the critical points from other guidance documents....

For the longest time, companies stayed away from trying out new tech stacks in pharmacovigilance (PV). But with the rise of generative AI, things are changing-fast. Big players like Bayer teamed up with Genpact to use AI for automating case intake. Sanofi joined hands with IQVIA to apply AI for end-to-end case processing. And these are just a couple of examples. As case volumes keep going up year after year, everyone’s now in a race to bring AI into the game-to cut costs, boost quality, speed up case processing, and let safety teams focus on what really matters....