Report on stakeholder meeting describing the model for a 21st century pregnancy data collection and signal detection system which should be able to replace traditional pregnancy registries

Task 21 Information and process needs barriers and requirements M136 UKZN NUTH LAREB UMAN UOSL MHRA ENTIS NVS GSK Sanofi AbbVieIn this task we will prepare in collaboration with WP1 content for a stakeholder workshop to establisha What are the information requirements and how do they differ by various stakeholders to enable informed decisions about prescribing dispensing regulating and using drugs in pregnancy and lactationb The requirements to instil Healthcare provider HCP and public confidence that reporting of medication exposed pregnancies is through a trusted secure and confidential system which supports patientprescriber clinical risk benefit assessment as well as regulatory guidance where use of a medicinal product has occurred or is being considered in pregnancy c The barriers that will need to be overcome to implement a harmonised pregnancy pharmacovigilance system for both public and private organisations that will be supported and accepted by various stakeholders d A proposal as to how existing capacity infrastructure and expertise could be better leveraged The output of this workshop will be an agreed model for a 21st century system for early pregnancy safety data collection analysis as an alternative to traditional pregnancy registries Components of this system will be further developed and trialled in demonstration projects within task 25 and based on the findings from these tasks a framework for the operation of a future endtoend PV system established in 26