Signal management process in the EU and worldwide is a fascinating PVG discipline which is full of contradictions! It is perhaps the most demanding line in terms of scientific and evidence based thinking in all of the PVG branches (Aggregate, RMP and signal). It also remains the most automated PVG…

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…

Today I tried a new approach. This is an article but more like slides… The so-called addiction terminology (such as drug/substance abuse, drug misuse, drug addiction, drug dependence) needs clarity in our minds, there are key differences between them and its good to understand the difference. I’ve tried to mention…

A few days ago, I wrote an article on medication misadventures, medication errors and related concepts on Linkedin. If not read already, you can read it here: Medication misadventures, medication errors and related concepts in PVG | LinkedIn The article you’re about to read concerns about various ways to present…

This article is about medication errors and related concepts. Why should I care about knowing medication errors (care enough to read an article worth 10–15 minutes, that is?) Medication errors are the most important and common preventable adverse drug reactions (side effects). MAH have obligations to reports and prevent medication…

Definitions and difference in PVG terms: Designated medical event (DME), Important medical events (IMEs), WHO critical terms and Adverse event of special interest (AESI) Its important to understand these key definitions and more importantly their differences.. Lets just dive in… Designated medical event (DME): • Adverse events considered rare, serious, and associated with a…

Let’s build a company: A start-up story minus the bullshit Authors: Harpreet Grover and Vibhore Goyal Pages: 256 (paperback), Printed in Oct 2019 Languages: English “Hard things about hard things but for Indian startups” Objective assessment of the book: Value for money: 10/10 Cost: 150 to 200 INR (PB), available on Kindle (79 INR) Length: 256 pages (PB) Time…

Book title: Before You Start Up: How to Prepare to Make Your Startup Dream a Reality Written by: Pankaj Goyal Pages: 200 (paperback), Printed in 2017 Languages: English and Hindi The Gut Punch (USP of this book): You are dreaming of starting up, scaling up, success, millions of $ and marrying that dream girl after you’re successful, rich and settled, then mummy comes and splashes you with cold water, you wake up to…