Indy Ahluwalia

Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019. In a press release, the European Medicines Agency (EMA) said: “The guidance document outlines the practical and simplified […]

The European Medicines Agency (EMA) is will be moving its offices from London to Amsterdam, due to the UK’s decision to withdraw from the European Union. According to a press release issued by the EMA, the relocation effort needs to be completed by the end of March 2019. The EMA currently employs close to 900 […]

The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]

Oracle Argus Safety 8.1.1 was officially released today, so I thought I would share a question that came up recently from a hosting customer. The customer asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that companies should […]

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also […]

Hi everyone, it’s Indy here. For those of you who may not recognize my name, I’ve been helping lead our Argus Safety installations for the past few years. I wanted to drop a quick note to personally invite you to the webinar I’ll be presenting next week. It’ll be relatively short, by design, but it […]

Due to the seriousness of adverse drug reactions, life sciences organizations perform something called “signal detection,” which is the process of evaluating potential safety signals. This entails looking at previously known associations between a drug and an adverse event, and looking at previously known drug-related issues that may be either improving or worsening. Not only […]

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

While there are many ways to define “adverse drug reaction,” let’s use one that is fairly simply to digest: an unintended, harmful response that is suspected to be caused by a medicinal product being taken under normal circumstances. According to some sources, adverse drug reactions are the sixth-leading cause of death in the United States, […]

E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]

It takes an average of 10 to 15 years and $2.6 billion for a drug to reach pharmacy shelves. While there are many steps in the process that contribute to this lengthy timeline and cost, no aspect of the process is more critical than proving the safety of a drug. Since a patient’s health is […]