Posts Tagged ‘Regulatory’

We have become a digital society. We use mobile devices to guide us through rush hour traffic, to find a great new spot for lunch, to research recipes for dinner, to do our shopping, to track our exercise, to entertain, to connect with friends and family, and to wake us up the next morning to […]

Tim Lind, global head of financial regulatory solutions, Thomson Reuters, sat down with Finextra at Sibos, the annual conference organized by SWIFT, to discuss the challenges financial services institutions face when it comes to regulatory change. To the put the regulatory climate in better perspective, Mr. Lind pointed out a few facts: Over the last […]

According to a survey conducted by The Depository Trust & Clearing Corporation (DTCC), the premier post-trade market infrastructure for the global financial services industry, 56% of respondents rated cyber risk a top-five concern, while 22% indicated it was their biggest concern. 50% of respondents said that the outcome of today’s presidential election is a top-five […]

The new U.S. Department of Labor (DOL) fiduciary rule is quickly revealing itself to be the most impactful regulation in the financial services industry in a long time. The investments that companies are needing to make in order to comply with the rule, which focuses on conflict of interest, are making the impact painfully clear. […]

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 […]

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 […]

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. When Do Companies Have To […]

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 […]