News
EMA Regulation Vote result – major gains for in silico
On 10 March 2016 the European Parliament through an overwhelming majority, voted in favour of requiring the EMA to take into account alternative models in clinical trials. The Avicenna Alliance has been working with supportive Members of the European Parliament to modernize elements of the 2004 EMA Regulation to enable the in silico market and provide certainty for investors and researchers in the in silico community.
EMA PRIME scheme – room for improvement
On 07 March 2016, the European Medicines Agency (EMA) launched their new Priority Medicines Scheme (PRIME) which aims to accelerate assessment of innovative medicines by shortening development time through stronger interactions between industry and the EMA. The scheme has a good number of similarities (at least in terms of goals) as the FDA designed “Innovative Pathway 2.0” which also aims to tackle the long time to market of new therapies.
Over the Horizon 2020
Ignoring the painfully unimaginative title of this article and getting to substance, the planning for the successor to Horizon 2020 is to start soon. This is no small task and to see how the 9th Framework Programme for Research and Innovation might turn out, it is worth having a look at why Horizon 2020 was brought in to replace FP7.
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.”
