Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.
|Articles|November 16, 2015
EMA Executive Director Guido Rasi Takes Office
Author(s)BioPharm International Editors
The new executive director of the European Medicines Agency begins appointment.
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Professor Guido Rasi has begun his five-year appointment as executive director of the European Medicines Agency (EMA). Rasi was nominated for the position on Oct. 1, 2015 and was appointed Oct. 13, 2015. Rasi served previously as executive director of EMA from November 2011–November 2014.
“I am very happy to be back at the helm of the Agency,” Rasi said in a
Professor Rasi previously served as EMA’s principal adviser in charge of strategy and was the director-general of the Italian Medicines Agency from 2008 to
2011. He also worked at the Institute for Experimental Medicine of the National Research Council, Italy and was the director of the Institute of Molecular Medicine of the National Research Council in Rome. Professor Rasi holds a degree in medicine and surgery, with specializations in internal medicine, allergology, and clinical immunology from the University of Rome.
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