Regulatory guidelines for adoption of in silico models in drug development

The VPHi is leading a working group in collaboration with representatives of EMA and a number of experts from different fields to identify the most appropriate tools for verifying and validating in silico models in drug development.

This adventure started back in April this year, when the VPHi organised a first workshop in Leuven with a restricted group of experts, mainly Belgium based, to discuss the challenges, the available tools and the gaps in assessing in silico models, from academia, industry and regulatory prospective. From this meeting, it clearly emerged that even though in silico technologies are penetrating healthcare at breakneck speed, there is a gap in assessing regulatory applications and a strong need from the community to solve it.   

This initial group of people has now expanded to form a temporary working group composed by representatives of all relevant stakeholders (academia, industry, regulators) that will focus on the creation of a white paper not only to demonstrate the value of in silico medicine technologies, but also to identify guidelines to agevolate the regulatory adoptions. 

The working group will regularly meet until the end of the year to be able to release the white paper in early 2020. 

We will keep you posted on the developments.

More info on this first workshop can be found here

Date: 09/11/2019 | Tag: | News: 1018 of 1589
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