Posts Tagged ‘pharmacovigilance’

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 […]

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 […]

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) […]

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 […]

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 […]

Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. Gartner’s List Of 5 Cool Vendors […]

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 […]

Bring out the popcorn! This Thursday, Dr. Rodney Lemery, one of our experts in drug safety and pharmacovigilance, will be delivering a webinar on the latest version of Oracle Argus Safety, the most widely used and trusted PV system on the market. This presentation is meant for everyone, whether you’re already using the system and […]

  Real-world data, the data generated about drugs and devices in real-world settings (e.g., routing doctor visits, hospital stays, etc.), can help develop more accurate product profiles. This is because the data comes from products that are no longer confined to the smaller, homogenous populations involved in clinical trials. More comprehensive profiles can help better […]

  On January 14, 2016, Perficient hosted a webinar titled Leveraging Siebel CTMS for Risk-Based Monitoring. We received some good questions during the webinar and figured we’d share them (and the answers) with you. 

  It’s that time of year again. The event for industry thought leaders and decision makers is just around the corner, and we’re hoping you’ll attend. Even if you can’t attend, we’re still giving you the opportunity to enter to win a SONOS wireless speaker…just because we like you. 

  In less than a month, Oracle will be hosting Oracle Health Sciences Connect Europe, a free event that is geared towards users of Oracle’s life sciences applications, as well as partners of the software company. The one-day meeting will take place on March 22, 2016, in London and will provide information on product roadmaps, […]