Historical control databases are established by many companies (i) enabling contextualization of results from single studies against previous studies performed under similar conditions, (ii) to properly design studies and/or (iii) to come up with quality control instruments. Although the use of historical control data in supporting inferences varies across different assays; one major opportunity is the derivation of so-called Virtual Control Groups (VCGs) for replacement of animals in the control groups and thus enabling a 3R strategy for future animal testing approaches.

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The virtual 11th CM was held on 16 and 17 of February 2021

The eTRANSAFE consortium gathered for the 11th time to assess and discuss recent project developments as well as short-term plans until the next assembly scheduled in June.

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Version 10 of the SR-Domain Specification and v1.1.0 of the SR-Domain Editor, developed by SME Partner PDS Consultants (PDS), were released in December 2020 for use by the EFPIA partners of eTRANSAFE.

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The Periodic Safety Update Reports (PSUR) Database with a web-based query function, developed by researchers from the Pompeu Fabra University (UPF) and Hospital del Mar Medical Research Institute (IMIM), was launched in December 2020.

The Database contains PSURs provided by the eTRANSAFE pharma partners, which are pharmacovigilance documents that assess the risk-benefit balance of a medicinal product. The PSURs incorporate summarised quantitative information on the adverse health events observed during clinical trials and the pharmacovigilance of medicines, constituting key documents in regulatory procedures.

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The 10th eTRANSAFE Consortium Meeting was held as a virtual conference on 23-24 of November 2020.

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