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Post-Market Surveillance Of Drug Safety

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

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What Are The Implications Of Not Complying With E2B(R3)?

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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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. The International Organization for Standards (ISO), Health Level Seven International (HL7), and European Committee for Standardization (CEN) collaborated to form the Joint Initiative […]

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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 […]

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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 […]

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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 […]

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U.S. Military Keeping A Close Eye On Supplements

  Megan Thielking from Stat News reports that a scientific journal took a close look at the impact nutritional supplements are having on U.S. military personnel. According to the article, 75% of people in the U.S. military take some type of dietary supplement every month. Since dietary supplements, such as weight-loss pills and multivitamins, don’t […]

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A Hospital That Shares Mistakes For The Greater Good

  This struck me as interesting: The Boston Globe wrote an article on how doctors at Brigham and Women’s Hospital (BWH) are encouraged to share medical errors. In fact, they are asked to do so, knowing that the information will be published in a case study-like format for the public to see. The objective is […]

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The Troubles With Adverse Event Reporting

  According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]

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Analysis Finds Reporting Delays For Serious Adverse Events

  According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]

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Activating Field Labels In Argus Safety

  One of the other major benefits of Argus Safety, Oracle’s drug safety and pharmacovigilance system, is the ability to maintain administrative tasks in an easy-to-use interface. The following blog post reviews some of the very simple possibilities of configuring Argus Safety to your own needs with minimal technical effort. 

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The Yellow Card You Can’t Argue With

  You can’t argue with it because it’s a good idea. Yellow Cards have gone digital. Not the ones used in soccer/football, but the ones used in the UK for reporting adverse events. When governments undergo digital transformation, you know it’s not a fad. After all, they’re not typically early adopters…of anything. Last week, the […]

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Accessing Previous Adverse Event Cases In Argus Safety

  The last post we wrote on Argus Safety features was about the system’s autocomplete functionality. Another great feature of Oracle’s safety and pharmacovigilance system is the ability to quickly go back to an adverse event case that you previously accessed. This can be done in just a couple of clicks from the menu, saving you […]

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Argus Safety 8.0 Released! Reporting And Integration Heaven

  Coinciding with the Drug Information Association’s (DIA) 51st Annual Meeting in Washington, D.C. last week, Oracle announced the newest version of its drug safety and pharmacovigilance system. Argus Safety 8.0, considered a major release, offers new features and functionality to help life sciences companies comply with ever-changing global regulatory requirements. The Standard Edition of […]

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