Posts Tagged ‘compliance’

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 […]

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 […]

Whenever an organization considers moving systems to the “cloud”, the first question that comes up is: “What about security?”  This is an extremely important question and is almost always a showstopper for people new to the cloud.  If you move data to the cloud and don’t consider the consequences of not complying with industry and […]

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) […]

There’s no question that financial institutions need cutting-edge technology to support growth. However, there is also no question that technology is not their core business. Therefore, it makes sense for them to partner – or even acquire – financial technology companies, which brings us to the topic of unicorns. What do unicorns have to do […]

Electronic document management systems (EDMS) offer excellent version control functionality, but, when it comes to collaboration, they tend to be…clunky, at best. SharePoint 2016, on the other hand, offers the best of both worlds: the security of an EDMS and the collaboration tools of, well, SharePoint. Here’s an example of how a global pharmaceutical company […]

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 […]

In April of this year, the U.S. Department of Labor finalized a new rule that is meant to protect individuals from receiving retirement investment advice that, in reality, may not be in their best interest. It’s a complicated rule that addresses the conflict of interest that financial advisors frequently encounter, such as receiving commission or […]

Smart machines, which encompasses a group of cognitive computing technologies such as advanced machine learning, natural language processing, and prescriptive analytics to make decisions and solve problems without human intervention, have been receiving more attention in recent years due to the rise and success of solutions like IBM’s Watson. A smart application learns and adapts […]

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 […]

The cloud is not new, but it remains incredibly important. Yes, leaders at financial services institutions continue to worry about the cloud’s ability to meet their strict security and privacy requirements. However, threats like cyberattacks are not stopping them from moving to the cloud. There are simply too many more advantages to operating in the […]