Skills Development Becoming Part of the Training and Qualification Process
Posted on 04. Mar, 2015 by Rob Sims.
Over the past year, the UL EduNeering Advisory Services team helped clients build a measurable and continuous On-the-Job Training and mentoring program that included documented assessments and mentoring programs. In a recent project, we helped a client build an “inventory” of role-based technical skills, focused on topics such as “Good Laboratory Practices” and “Proper Equipment [...]
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What are Companion Diagnostics?
Posted on 19. Feb, 2015 by Karl Kapp.
With the advent of personalized medicine, a key factor in ensuring the right medicine is available for the patient is companion diagnostics. Companion diagnostics are medical devices that help doctors decide which treatments to offer patients and which dosage to give, tailored specifically to the patient. According to the FDA, a companion diagnostic device can [...]
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The New England Patriots Have a Compliance Issue
Posted on 13. Feb, 2015 by Karl Kapp.
If you are any kind of sports fan, a person who occasionally listens to network news, checks cnn.com or in any other way are paying attention to the world around you then you know the biggest issue recently in the world of sports is Deflate-Gate. For those of you who may not know, the New [...]
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FDA Moving from Mini-Sentinel to Sentinel
Posted on 13. Feb, 2015 by Karl Kapp.
In May 2008, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of FDA’s Sentinel Initiative, a long-term program designed to build and implement a national electronic system for monitoring the safety of FDA-approved drugs and other medical products. So in 2009, the FDA [...]
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What are Biosimilars?
Posted on 06. Feb, 2015 by Karl Kapp.
One growing area of the life science field is the creation and use of biosimilars. A biosimilar exists when there are no clinically meaningful differences between a biological product and its reference product in terms of the safety, purity and potency of the product. A simplistic definition of a biologic is that it is a [...]
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Helpful Calorie Counting
Posted on 04. Feb, 2015 by Karl Kapp.
Would knowing how many calories are in that restaurant’s signature dish deter you from ordering it? Would the listing of the 2,785 calories that come with your dessert serve as a warning against ordering it? The FDA is banking on the hope that full knowledge of the calorie count on a restaurant’s menu will at [...]
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Breakthrough in Field of Wireless Electronic Implants
Posted on 29. Jan, 2015 by Karl Kapp.
Recently, researchers have delivered an antibiotic treatment to laboratory mice with a bacterial infection using the first resorbable wireless electronic implant. The device is made of silk and magnesium and was developed by researchers at Tufts University School of Engineering and researchers at University of Illinois, Champaign-Urbana. The device worked by delivering heat to infected [...]
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Top Health Issues of 2015
Posted on 29. Jan, 2015 by Karl Kapp.
According to a recent report released by PwC’s Health Research Institute, the $2.8 trillion US healthcare industry is undergoing profound transformation. The report outlined ten top health issues for 2015 including the fact that consumers are bearing more of the cost of their own care as well as making more decisions, and manufacturers are gearing [...]
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China’s Imports Growing Larger and Larger
Posted on 12. Jan, 2015 by Karl Kapp.
Margaret A. Hamburg, M.D., the Commissioner of the Food and Drug Administration, recently returned from a trip to China, and has some interesting facts and figures to report: Of the 200 countries that export their products to the United States, China ranks first in exports (in dollar value) to our nation. China is the sixth [...]
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