Posts Tagged ‘Regulatory’

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 […]

IT system consolidations seems to be an ongoing trend in the financial services industry. In March, I shared J.P. Morgan’s plan to shrink the number of IT applications it uses by an overall 25%. Today, the story is about Deutsche Bank, Germany’s leading bank, who has a strong position in Europe and a significant presence […]

I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete […]

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]

  On January 8, 2016, the FDA issued a warning letter that caught my attention. I can’t remember why I initially opened it; maybe because the company’s name had “pharm” in it, as opposed to “seafood” (which seems to be there a lot!). Once inside the letter, I found this in the opening paragraph: “This […]

  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. 

  Similar to many industries, but arguably one of the most challenging, the life sciences sphere undergoes regulatory and compliance changes. Each country, group of nations, and regulatory body proposes different guidelines at different times. And, even though it could take several years for the changes to go into effect, when they do, you’d better […]

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions. 

  In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness. 

  Naming drugs and medical devices is an art form that requires creativity, knowledge of linguistics, and an understanding of how to navigate the regulatory landscape. It’s easy to think of names, but coming up with ones that are meaningful and memorable, yet different enough than anything currently on the market, is another story. The International […]

  Wow, it’s not often you hear about executives from life sciences companies getting jail time. But in the case of the former CEO of OtisMed, that’s just what he got: two years and a small fine. The company also agreed to pay more than $80 million to resolve other charges. Without receiving FDA approval, […]

  Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]