Kristin Gordon Corporate Director Quality and Regulatory ALERE Kristin Gordon is the Director of Quality and Compliance, the Americas, for Alere Inc. She was appointed to her current position in March 2011. Previously, she served as Director of Quality and...
Robert Labaczewski Associate Director Quality Group BRACCO DIAGNOSTICS Robert has over 18 years of experience in quality systems and engineering in the Medical Device Industry, with extensive knowledge around QSR 820 and ISO 13485. Robert is currently the...
“Companion Diagnostics are medical tests that identify patients within a disease category who are most likely to positively respond to a particular drug, given that they have the exact molecular defect as other individuals with the disease and for whom the drug...
In a new article via MassDevice.com, the Embargo Group said, “New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued...
According to biospace.com, Endo Pharmaceuticals acquired Par Pharma for $8.05 billion. In the article, the CEO of Endo Pharmaceuticals says: “This transaction with Par builds upon our generics growth, adding a strong portfolio of high barrier-to-entry and attractive...
