Posts Tagged ‘Safety’

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 […]

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 […]

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 […]

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 […]

At this year’s MedCity CONVERGE, a two-day summit in which executives convene to discuss the future of innovation in healthcare and life sciences, digital was a hot topic. In a presentation titled “Digital Health’s Arrival (Or Not) In Pharma,” Dr. Naomi Fried, an expert on digital health innovation and past chief innovation officer at Boston […]

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 […]

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 […]

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 […]

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) […]

E2B(R3) doesn’t have a direct translation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidelines that have designated “E” to stand for efficacy. The work carried out by ICH under the efficacy heading relates to the design, conduct, safety, and reporting of clinical trials. It also […]