Posts Tagged ‘signal detection’

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 […]

The Role Of Signal Detection In Drug Safety

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 […]

Top 5 Life Sciences Blog Posts From May 2017

Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. How To Import Data Into Siebel […]

[This Week] Mining The Internet For Safety Signals

Online communities and social networks like Twitter and Facebook have become important real-world data repositories that can be leveraged by life sciences organizations to gain insight into the patient experience, as well as to identify potential safety issues related to drugs and devices – otherwise known as safety signal detection. This week, my colleague, Dr. […]

Researchers Are Scouring EHR And FAERS Data For Safety Signals

  Patients who are being treated for diseases, such as cancer, often require multiple drugs to manage their conditions. For example, patients are often prescribed drugs that treat the actual disease, while others are meant to manage side effects from those drugs. Many of these patients can probably attest to inquiring about or doing their […]

How Bad Data In FAERS Wreaked Havoc On Regeneron

  An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]

Detecting Adverse Events With Google? The FDA Is Interested.

Editorial Credit: Gil C / Shutterstock.com Analyzing Google searches to uncover previously unknown adverse events isn’t news, per se, but it looks like it could be gaining traction with the FDA. According to a recent Bloomberg article, the FDA’s public calendar shows that several employees from Google met with the FDA to discuss the possibility […]

Why We Love Signal Detection (And You Should, Too!)

The amount of time and money it takes for a drug or medical device to be developed and pushed to market is staggering and continues to grow. However, more often than not, once a product gets approved, the maker enjoys watching it flourish in the global marketplace for many years. Unfortunately, there are situations when […]

The Importance Of Interprofessional Education In Drug Safety

In recent years, we have seen many changes to the global “face” of product safety (FDA, 2009). Arguably, these changes modify the traditional focus of product safety from a case management and alert reporting strategy to include a more preventative, pharmacovigilance strategic focus. In order to successfully adopt these changes, it is critical that we […]