The EESC calls for the creation of Good Simulation Practices
The European Economic and Social Affairs Committee (EESC) has specifically called for the creation of Good Simulation Practices as part of the steps needed to speed up clinical trials that include GMOs.
More particularly, the EESC published a report entitled "Proposal for a Regulation of the European Parliament and of the Council on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease", in which it urges the Parliament and the Council to ensure that clinical trials with vaccines and medicines containing GMOs to treat or prevent COVID-19 are started as soon as possible.
Besides, the EESC notes that there is much regulatory uncertainty surrounding the use of evidence derived from computer modelling and simulation (CMS). The EESC, therefore, recommends that the Commission work to develop good simulation practices, to be used when deploying CMS solutions in healthcare, especially in pre-clinical activities and in clinical trials.
Moreover, the EESC also considers that the pharmaceutical and medical device industries should be expected to present real-time data daily to the authorities in the interest of transparency in order to speed up the development of therapies to counter COVID-19.
The full press-release and publication can be found here!