Call: H2020-JTI-IMI2-2017-13-two-stage
Project number: 821520
Duration: 60 months
Start: April 2019
End: March 2024
Total budget: € 15,299,991.00 and in-kind contribution
ConcePTION
Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation
Project abstract
Conception is developing an ecosystem for generating and disseminating real world evidence on the use of medicines in pregnancy and during breastfeeding, the effectiveness and safety of these medicines. The evidence will be generated through a network of women’s health databases held by consortium partners and third parties, and published for access by women, healthcare providers and other decision makers including medicines regulators. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, pregnant women and their children through a large network.
i~HD leads a work package on multi-stakeholder engagement and consensus building on the acceptance of real-world evidence, in particular interacting with medicines regulators such as EMA. It also leads a task on information governance and GDPR compliance.
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