Month: September 2016


The Promise of Biosimilar Drugs

In 2006, the European Medicines Agency granted its first approval of a biosimilar drug, the human growth hormone, Omnitrope™ (Sandoz), and opened the doors of opportunity for this emerging field of medicine. In 2010, President Obama signed into law the Biosimilars Act, and on March 6, 2015, the FDA formally approved its first …

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Creating High Performance Pharmacovigilance Teams in Diverse, Global Environments

Individuals often interpret the same information and terms in dramatically different ways. Multiple factors drive these variances, including culture, background, education, training, and personal biases. Unfortunately, this means when diverse global teams converge in Drug Safety and Pharmacovigilance environments, it can compromise the accurate capture and reporting of critical safety …

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