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Medication Safety in Pregnancy

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IMI ConcePTION Project 2019 - 2024

The EUROmediCAT Network partipates in the ConcePTION Project: 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.


This project funded by the EU Innovative Medicines Initiative started in April 2019 to run for 5 years. EUROmediCAT is conducting Workpackage 1: Secondary use of existing data sources for studies of medication safety in pregnancy. This involves the use of registries and healthcare databases.


Five Demonstration Projects will be carried out, in the therapeutic areas of neuropathic pain, depression, multiple sclerosis, SLE, migraine and breast cancer. These projects have been chosen to cover a wide range of methodological issues, as well as meeting important evidence gaps.


Workpackage 1 is led by Helen Dolk. The Demonstration Projects are led by Christine Damase-Michel, Maria Loane, Joan Morris, Hedvig Nordeng and Maarit Leinonen. Other EUROmediCAT partners include Sue Jordan, Anna Pierini, Amanda Neville, Clara Cavero, Jorieke Kammen-Bergman. Many EUROmediCAT members are also participating, as Data Access Providers, to the construction of an informatics platform in Workpackage 7. For more information, see

Glossary of Terms used in Pharmacolvigilance and Pharmacoepidemiology

A plethora of terms (sometimes confusing) are deployed in pharmacolvigilance and medicines management research and practice. This glossary aims to clarify terminology, and its provenance, as a component of the quality initiative in Conception and other studies. Whilst some definitions are taken from official sources, others, absent in these sources, are drawn from contemporary literature with references. We hope readers will find this useful.

Working Definitions & Glossary for WP1 of IMI Conception




T1.5 SSRIs

T1.5 MS

T1.5 Gabapentinoids