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 […]
Posts Tagged ‘FAERS’
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 […]
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) […]
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 […]
FDA’s New Chief Is A Tremendous Blessing For Industry
Dr. Robert Califf, a cardiologist who has spent most of his career at Duke University, was confirmed by the Senate on February 24, 2016, to be the next FDA commissioner, following President Barack Obama’s nomination in September 2015.
Researchers Are Scouring EHR And FAERS Data For Safety Signals
Patients who are being treated for diseases, such as cancer, often require multiple drugs to manage their conditions. For example, patients are often prescribed drugs that treat the actual disease, while others are meant to manage side effects from those drugs. Many of these patients can probably attest to inquiring about or doing their […]
How Bad Data In FAERS Wreaked Havoc On Regeneron
An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]