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 […]
Financial Services
Servicing Customers In Financial Services With CX Technology
It’s no secret that customer satisfaction scores go up when customers consistently get what they want. When they have unanswered questions about your products and services, they’re not likely to become your biggest cheerleaders. And, chances are that if your prospects find themselves with questions that can’t be answered, they’re not going to convert. We […]
Citi, State Farm, T. Rowe, Visa, & Zurich: Apps For Noncustomers
A while back, I wrote a blog post that shared ways in which the financial services industry can leverage social tools to win over existing customers, cultivate new ones, and become more efficient in their business operations. One example was how Barclays created a new product called Barclaycard Ring, which gives cardmembers the opportunity to […]
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 […]
Fighting Cybercrime, From JPMorgan To Bank Of America
A new quarterly Cybersecurity Market Report was published by Cybersecurity Ventures, projecting $1 trillion will be spent on cybersecurity between 2017 and 2021. According to Steve Morgan, founder and editor-in-chief of Cybersecurity Ventures, the increase in cybercrime, such as ransomware and malware, and the large number of digital devices being rapidly deployed by organizations and […]
BofA CEO Shares 3 Keys To Success For Today’s Banks
Dennis K. Berman, financial editor of The Wall Street Journal, asked one of the simplest, yet greatest questions anyone could ask an executive at a major financial institution. During WSJ’s CFO Network conference, he asked Bank of America Chairman and CEO Brian Moynihan the following: “If you were building a bank today from scratch, what […]
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 […]
Funny Fiduciary Rule Video Surpasses 4 Million Views
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 […]
3 Ways To Bank On Your Phone (And How They Compare)
There are many ways to bank. You can call your financial institution on the phone, go to the nearest brick-and-mortar branch, or hop online. While these are the most traditional ways of banking, there’s another option that’s quickly growing in popularity: mobile apps. As we mention in one of our guides, mobile banking raked in […]
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 […]
Protecting You And Your Clients Through Technology And Strategy
Every industry experiences cybercrime, but probably none more than financial services, at an average annualized cost of $13.5 million. If you look at the Breach Level Index, you will notice that some type of security breach occurs at financial institutions almost daily. These breaches can involve anywhere from a handful of records to tens of […]
How To Comply With IDMP Regulatory Requirements
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 […]