Posts Tagged ‘Safety’

Building Better Safety Profiles With Real-World Data & Evidence

The use of real-world data has exploded in recent years and will continue playing a crucial role in 2018. Almost every major pharmaceutical and medical device company conducts real-world studies to build better safety profiles for their products, as well as support initial study findings. Real-world data can come from a variety of sources including […]

Top 5 Pharma & Medical Device Blog Posts From October 2017

Now that November 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 October – they’re ranked in order of popularity, with number one being the most viewed piece. Aggregate Report Preparation In Safety […]

The Driving Force Behind Autonomous and Connected Vehicles

The benefits of driverless cars are limitless. According to the United Nations, each year 1.25 million people die in auto accidents globally (40,200 in the U.S. alone), and as many as 50 million are injured. More than 90% of accidents are due to human error or distraction. Forty percent of fatalities are related to drunk […]

Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

What The FDA Requires Of Drugs On The Market

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

All You Need To Know About Oracle Argus Safety 8.1 In 30 Minutes

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 […]

Learning Opportunity: Webinar on Maximo HSE Manager; July 14

As part of the Maximo Friday webinars, one of the next sessions will discuss the Industry add-on called Health, Safety & Environmental Manager (HSE). It’s not just for Oil & Gas clients, others can use it too.  This add-on can help you identify and manage operational risk within your organizational work. Previous versions of IBM […]

EudraVigilance: Some Things To Consider Right Now

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 […]

How To Determine Whether Your IT System Is Regulated

A couple weeks back, I launched a brief blog series about assessing and mitigating risk with regulated IT systems. This week’s post will cover the first part in a four-part approach you can use to do just that: assess and mitigate risk. Part One: System Regulated Status The first step is to determine whether a […]

IMC 2016 EXPO – 3 safety observations

It was actually during the setup of the show that I noticed and snapped this picture and thought about a few things.  There’s a warning on every ladder produced that states the highest step / rung and which side should be used on a folding ladder.  Clearly this guy didn’t pay attention to it or […]

What Are The Implications Of Not Complying With E2B(R3)?

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]

Do Commercially Available Safety Systems Comply With E2B(R3)?

Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]

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