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Regulatory Affairs
Regulatory Affairs (RA) is a profession that ensures compliance within industries such as: pharmaceuticals, energy production, banking, and agrochemicals. RA works with government on all levels in order to monitor and advise on laws that coincide with a business. Such partnerships include: Food and Drug Administration, Securities and and Exchange Commission, and the Department of Energy.
APR 06, 2016 | 10:30 AM
This session will provide an update on PAMA, related coding initiatives, and what we are seeing from the payor perspective so far this year. Participants will have a deeper understandin...
NOV 11, 2015 | 9:00 AM
FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests. This use of “enforcement discretion” has been un...
SEP 30, 2015 | 1:30 PM
Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the...
SEP 16, 2015 | 12:00 PM
Nanotechnology, the engineering and manufacture of materials at the atomic and molecular scale, is used at BIND Therapeutics to develop novel Accurin™ nanomedicines that utilize cytotoxic age...
SEP 03, 2015 | 1:30 PM
Natural preservation is often cited as effective and “safe” alternative to traditional synthetic preservative systems. However, the so-called natural preservatives bring a number...
SEP 03, 2015 | 6:00 AM
Preservatives have been under attacks by NGO's and their willing accomplishes-the media and the marketers of cosmetics. But with all their science fiction and negative statements, what are t...
FEB 05, 2015 | 10:30 AM
C.E. CREDITS
In the context of an experimental project requiring surgical preparation of animals, training is not only required for technicians lacking a strong surgical background but also for more exper...
FEB 04, 2015 | 6:00 AM
C.E. CREDITS
Soiled-bedding sentinels are not always efficient in detecting pathogens in rodent colonies. In this context, PCR-based testing can be more sensitive and is being advocated as adjunct to trad...
DEC 03, 2014 | 9:00 AM
Contemporary serologic testing has revolutionized the field of celiac disease. Highly accurate serologic assays have shown the prevalence of celiac disease to be nearly 1:100 in many populat...