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 […]
Posts Tagged ‘clinical’
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) […]
Manage Regulatory Submissions And SOPs With Microsoft SharePoint
Electronic document management systems (EDMS) offer excellent version control functionality, but, when it comes to collaboration, they tend to be…clunky, at best. SharePoint 2016, on the other hand, offers the best of both worlds: the security of an EDMS and the collaboration tools of, well, SharePoint. Here’s an example of how a global pharmaceutical company […]
Pfizer Says “Yes” To Oracle
Very good news out of Oracle this week. After a thorough review of solutions on the market, Pfizer chose to implement what can essentially be seen as Oracle’s complete suite of clinical and drug safety applications. This doesn’t necessarily come as a surprise, since the pharma company has been a long-time user of Oracle’s legacy […]
What Is E2B(R3)?
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 […]
E2B(R3): Inside Scoop For Product Safety Teams In Life Sciences
The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]
3 Fundamental Shifts Pharma Needs To Make To Survive Digital
Over the past several weeks, I’ve published a series of posts that focus on segments of an article published by McKinsey & Company called “How pharma can win in a digital world.” (See the bottom of this post for links to the previous posts.) At the end of the McKinsey article, the authors describe “three […]
How To Automate Clinical, Safety, And Business Processes
The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process. Join […]