Currently two official reports are published on the accident, which had been commissioned by the French Medicines Agency ANSM and French Authority for Social IGAS. Both reports contains a number of recommendations with the goal to make such Phase I studies safer. EMA two expert groups from EMA will now address the issue.
Source:
http://www.pharmazeutische-zeitung.de/index.php?id=63539
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Friday, 27 May 2016 14:17
Phase I studies: EMA is going to revise regulations Featured
The European Medicines Agency (EMA) will revise the regulations which are applied when drugs are tested in humans for the first time. This intervention follows in response to an incident from January this year, as a proband died and five others seriously was hurt during a phase I study in Rennes, France.
Dr. rer. nat.
Menschen für Tierrechte - Tierversuchsgegner Rheinland-Pfalz e.V.