Those who won’t adapt would cease to exist. — Once upon a time, in a world not too different from ours, handmade clothing was the norm. Skilled artisans would spend countless hours creating beautiful garments, each one unique and crafted with care. But as technology advanced, machines were invented that could produce clothing at a much faster rate and…

In today’s article, the subject is relatively lesser-known step in the EU signal management process. Signal Prioritization is obscure but very important to understand at the same time. I call it obscure because you won’t find all of the information below in one place. …

This Friday, I write about two concepts in Pharmacovigilance. Even if its a short to the point kind of article, these two concepts are important to understand for all PVG professionals and patients who take these medications alike. Without further ado, lets jump right in! Black box warning: A warning that appears on…

This is an article about RMPs- Risk Management Plans in PVG and important concepts to understand. I have divided it into two parts, the first has concepts that need to be understood and are described in detail. Whereas the second half of the article has 27 key definitions relevant to…

In this post we’ll learn 3 project management frameworks and 1 skill that help data scientists steer projects towards success — Most data science projects are time fixed ventures with limited budget. While it’s healthy that data science projects have some loose “free-time” due to their scientific nature, the fact that resources (time, money or people) are limited, justifies that data science projects have to be planned carefully. …

Learn the most common metrics you can use to evaluate your regression models — in this article we will explore 4 metrics including their implications and assumptions — Regression problems are one of the most common problems to solve with Data Science and Machine Learning. When you want to predict a target with a (theoretical) number of infinite values, you are dealing with a regression problem — some examples are:

Safety concerns (risks- important identified risks, important potential risks and missing information) can be considered the most scrutinized and most important part of any safety document such as PSUR/PBRER or RMP. In PBRER, section 16 (esp 16.1 and 16.4) provide list and discussion on safety concerns whereas in RMP: part II, module SVII Identified and potential risks do. Safety concerns include important identified and important potential risks, and missing information and in this article I intend to discuss each of them…