Workshop on benefit-risk of medicines used during pregnancy and breastfeeding

Medicine use in pregnancy is common for treating acute as well as chronic disorders. This includes use while the woman does not yet know she is pregnant, and treatments for conditions that can be pregnancy-specific, worsened by pregnancy, or require continued medication during pregnancy. In Europe, very few medicines are licensed explicitly for use in pregnancy and breastfeeding. This is due to the limited understanding of benefits and risks to mother and child and how they should be balanced.

It is EMA’s ambition that in the medium- to long term, women should have sufficient information, provided appropriately, to enable decision making on their medical treatment, given their (plans for) pregnancy or given they wish to breastfeed their baby.

The PCWP and HCPWP would like to provide an opportunity for their members and the wider stakeholder community to contribute towards developing and implementing EMA’s strategy for developing better information regarding benefits and risks of medicines in pregnancy and breastfeeding, and to encourage a discussion on how to progress towards obtaining evidence on medicine utilisation and safety for this population

Workshop Objectives

1. Share experiences and expectations from real life and clinical practice;
2. Provide input into the draft EMA strategy on drug safety in pregnancy and breastfeeding;
3. Discuss how to progress with implementing the 'EMA strategy towards obtaining evidence on medicine utilisation and safety for pregnant and breastfeeding women' report.