News
Avicenna Alliance proclaims victory in EMA Regulation
The Avicenna Alliance, can claim a major victory in the revised EMA Regulation with the introduction of new text supporting modelling and simulation and predictive medicine in medicinal product development.
EMA Regulation amendments call for framework for in silico
Amendments calling for the creation of a framework for in silico medicine have been tabled by MEP Martin Häusling (Greens/EFA, Germany) to the EMA Regulation Report by Claudiu Ciprian Tănăsescu (S&D, Romania). This report, currently being discussed by the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) Committee would amend the 2004 EU Regulation on the placing on the market of medicinal products and the establishment of a European Medicines Agency.
US Legislature says FDA should use in silico methods
In an unprecedented victory for the in silico community in the US Congress has put forward a bill that “urges FDA to engage with device and drug sponsors to explore greater use, where appropriate, of In Silico trials for advancing new devices and drug therapy applications.”
