Regulatory Compliance

If you work in financial services, you may have noticed that your executives aren’t getting enough sleep. They’re most likely tossing and turning at night, thinking about the shift to digital, stringent regulations, and, as The Financial Times recently said: “Bank bosses perhaps are worried most about not being publically humiliated by a failing grade.” […]

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 […]

On April 11, 2016, the Centers for Medicare and Medicare (CMS) announced an initiative called the Comprehensive Primary Care (CPC+). This initiative, which builds on CMS’s previous Comprehensive Primary Care (CPC) initiative, is designed to “improve the quality of care patients receive, improve patients’ health, and spend health care dollars more wisely 1” and similar […]

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 […]

Results from the most recent National Financial Capability Study (NFCS) were released last month by the FINRA Investor Education Foundation (FINRA Foundation). The findings, which include data from more than 27,000 U.S. adults, continue to reiterate the importance of providing people with financial education to help them better manage their money. According to an infographic that depicts […]

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 […]

A couple of weeks ago, I shared a brief overview of a new rule the U.S. Department of Labor (DOL) recently finalized. While it’s certainly nothing to laugh about, comedian and host of “Last Week Tonight with John Oliver” the man himself, John Oliver, was able to make light of it. In fact, as of […]

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 […]

The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57. The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to […]

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) […]