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Predicting the safety of medicines in pregnancy: A workshop report

Clements JM; Hawkes RG; Jones D; Adjei A; Chambers T; Simon L; Fowkes A; Prior H; Sewell F; Stemplewski H; Berry N; Price S; Pirmohamed M; Piersma H; Waxenecker G; Barrow P; Beekhuijzen MEW;

In 2017, a UK Commission on Human Medicines (CHM) Expert Working Group [6] produced a set of recommendations aimed at improving the evidence base for medicines taken during pregnancy and lactation. One such recommendation was the delivery of a workshop to consider how non clinical data could be made more predictable and accessible, as well as the feasibility of using computer modelling and molecular structural alerts to generate safety signals from in vivo and in vitro data. This workshop was held in January 2019. The MHRA then organised the workshop bringing together experts from different backgrounds (academia, regulators, industry, CROs, software vendors) to discuss the status of the current developmental toxicity testing paradigm and the challenges and opportunities presented when considering novel approaches for the purpose of improving the predictability of non clinical data.