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Managing safety risks in pharmaceuticals is a complex, ongoing challenge. Every new drug or therapy carries potential risks that must be carefully identified, assessed, and controlled to protect patients and ensure regulatory compliance. This is where a Risk Management Plan (RMP) plays a crucial role. In this post, I will explain what an RMP is, how it works in the pharmaceutical industry, and how companies manage safety risks over the long term. Pharmaceutical scientist ana

Drug safety isn’t assessed in the same way throughout a medicine’s life. That idea took me a while to properly grasp – and it’s exactly why two safety reports that sound very similar, PSUR and DSUR, both exist. Once I understood when each one is used, the distinction finally clicked. Medical professional analysing pharmacovigilance reports What is a PSUR? A PSUR is a document that pharmaceutical companies submit regularly after a drug has been authorized for marketing. Its ma

When I first started learning about pharmaceutical regulation, most of my focus was on clinical trials, approvals, and safety monitoring. Distribution felt secondary – almost logistical rather than regulatory. But learning about Good Distribution Practice (GDP) completely changed how I see that part of the lifecycle. Pharmaceutical warehouse showing organized storage of medicines What Is Good Distribution Practice? Good Distribution Practice refers to a set of guidelines and

As I learned more about regulatory affairs, I kept coming across the term “variation.” Type IA Type IB Type II At first, they just felt like labels I was expected to memorise. But I didn’t really understand why they existed, or what made one different from another. So I took time to step back and understand variations as a system – not just categories. This post is the explanation that finally made sense to me. Detailed regulatory document with highlighted IA, IB, and II va

Before I started learning about the pharmaceutical industry properly, I assumed drug approval was the finish line. Once a medicine passed clinical trials and received regulatory approval, I thought the hard work was done. What I didn’t realise was that approval is really just the beginning. That’s where pharmacovigilance comes in. Healthcare professional analysing pharmacovigilance data Why approval isn’t the end Clinical trials are carefully designed, controlled, and limited

After learning what the MHRA does and how Regulatory Affairs fits into the picture, I realised there was still a gap in my understanding: clinical trials I knew there were different phases – Phase 1, Phase 2, Phase 3 (and sometimes Phase 4) – but if someone asked me what actually happens in each phase, I wouldn’t have been able to explain it clearly. So I decided to sit down and understand clinical trials properly – not as definitions to memorise, but as a logical process. Th

After learning what the MHRA is and how medicines get approved, I kept seeing another term everywhere: Regulatory Affairs (RA) It comes up constantly in pharma job descriptions, conversations, and industry posts... but when I asked myself what RA actually do day to day, my answer was pretty vague. So I decided to sit down and properly understand it. This post is my attempt to explain RA in a way that finally made sense to me. Researchers in a lab conducting drug development

When I first stepped into the pharma world, MHRA  was a word I kept seeing everywhere – press releases, packaging, LinkedIn posts, even in conversations that I quietly nodded through. I had a rough idea that they “approve medicines”… but what does that actually  mean? Who are they approving it for? And what happens after  a drug gets approved? This week I sat down, researched properly, and wrote this post to make it make sense – for me first, and for anyone else who’s learnin