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 […]
Posts Tagged ‘E2B’
Consider This When Migrating To Argus Safety
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 […]
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 […]
Top 10 Life Sciences Blog Posts Of 2016
While we rolled into 2017, I thought it would be neat to see what our readers were, well, reading. Without further ado, here are the top 10 blog posts Perficient’s life sciences practice wrote that seemed to be popular among readers. They’re ranked in order of popularity, with number one being the most viewed piece. The 8 […]
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 […]
Top 5 Life Sciences Blog Posts From July 2016
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 […]
Does E2B(R3) Impact Companies With No Safety Reporting System?
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 […]
What Is The Pathway To E2B(R3) Compliance?
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 […]
When Do Companies Have To Begin Complying With E2B(R3)?
In the United States, if a company is transmitting vaccine or device information to the FDA, it should already be reporting in E2B(R3) format. For companies reporting solely to the FDA Adverse Event Reporting System (FAERS), no official deadlines have been published. In Europe, drug companies who report to the EMA will need to comply with […]
How Does E2B(R3) Affect Companies With Global Operations?
Currently, two of the FDA branches have released guidance documents and have implemented a form of E2B(R3). Center for Biologics Evaluation and Research (CBER) has released “Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines” and the Center for Devices and Radiological Health (CDRH) has released “Technical Information on eMDR.” While both of […]
What Is The Difference Between E2B(R2) And E2B(R3)?
After the release of E2B(R2), the ICH realized that technical specifications should no longer be developed in isolation. E2B(R3) is the first technical specification to be developed through a new collaborative approach. E2B(R2) Vs E2B(R3): Regulation and Interoperability The International Organization for Standards (ISO), Health Level Seven International (HL7), and European Committee for Standardization (CEN) […]