Posts

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 This time, I want to shift focus to the FDA’s draft guidance on AI, released in January 2025.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....

A few months ago, I had an insightful conversation with a PV leader who asked about the current opportunities within PV technology for a CRO. Like most, my initial response was a generic suggestion—embrace AI, automate processes, and so on. However, this post isn’t about the usual recommendations you hear everywhere. Now that I’ve spent considerable time in the pharmacovigilance domain, I’ve encountered specific bottlenecks that persist in PV technology companies....

Over the past year, I’ve had the opportunity to interview for several senior Product Manager roles. After going through multiple interviews, I noticed a pattern in the questions being asked, and I thought it would be helpful to share them here on my blog for those preparing for similar positions. The questions I encountered typically fell into four main categories: Categories of Interview Questions By sharing these insights, I hope to provide a useful resource for fellow product managers looking to advance their careers....