Posts Tagged ‘pharmacovigilance’

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 […]

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 […]

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 […]

Next week, we are exhibiting at Oracle Industry Connect (OIC) 2017 in Orlando, Florida. For those not familiar with OIC, it is a conference dedicated to a variety of verticals, including Life Sciences and Healthcare. Prior to the existence of OIC, the Annual Oracle Health Sciences User Group (OHSUG) Meeting was an event devoted to users […]

Now that December 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 November – they’re ranked in order of popularity, with number one being the most viewed piece. 10 Headlines That Suggest Donald Trump […]

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. […]

Bayer recently launched its first Facebook ad. The ad also happens to be the first time Facebook has allowed a company to put important safety information (ISI) in a scrolling format, something that pharmaceutical companies have long been able to do in banner ads. In addition, the social media giant is also enabling drug companies […]

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 […]

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 […]

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. When Do Companies Have To […]

The issue is not the type of system used to collect adverse event data, but rather how the data is submitted to the FDA, EMA, and MHLW. If an organization is using spreadsheets to collect safety data or is unable to transmit data via E2B, it will have to report the data via a web-based […]

Companies who are currently submitting reports using the E2B(2) format should already be planning the move to E2B(R3). If a robust safety and pharmacovigilance system is already in place, there are likely just a handful of technical changes that need to be made in order to meet the new regulations. For example, system configuration changes […]