Regulatory Compliance

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) […]

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 […]

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 […]

In April of this year, the U.S. Department of Labor finalized a new rule that is meant to protect individuals from receiving retirement investment advice that, in reality, may not be in their best interest. It’s a complicated rule that addresses the conflict of interest that financial advisors frequently encounter, such as receiving commission or […]

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 […]

Recent news from the Financial Industry Regulatory Authority (FINRA) reminds us of the importance of having a solid anti-money laundering (AML) compliance program. A well-known financial services company was fined $17 million for not having sufficient processes that could enable them “properly prevent or detect, investigate, and report suspicious activity.” While the organization significantly grew […]