Posts Tagged ‘FDA’

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 […]

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 […]

Now that July 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 June – they’re ranked in order of popularity, with number one being the most viewed piece. Pfizer Says “Yes” To Oracle What Is […]

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 […]

If you’re in the biotech business, you’re likely closely following the Sarepta saga, or, at the very least, you’re hearing about it in passing because everyone around you is talking about it. Sarepta Therapeutics, a Cambridge, Massachusetts-based company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and […]

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 […]

We’ve talked a lot in this blog about the use of electronic health records (EHRs) in clinical trials. Recently, my colleague wrote about it on our healthcare blog, so, I thought I would share her post with my pharma and CRO friends. While our previous posts focused on the use of EHR for subject recruitment […]

The Food and Drug Administration has issued a draft guidance stating that in order to see the highest success, clinical trial leaders must use electronic health records (EHR) that promote health data interoperability. In the draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations, the FDA indicated that health data interoperability may […]

The other day, I was on a business development call in which the Appian platform was discussed. Appian happens to be a “Leader” in Gartner’s 2015 Magic Quadrant for Intelligent Business Process Management Suites. Not too shabby. The presenter talked about Perficient’s successes with Appian in financial services and healthcare, but when I heard him […]