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

• Date:
  Tuesday, 22 September 2020
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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.

Documents

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

Draft

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

Presentation - Why is it so difficult to treat pregnant & breastfeeding womenand what can EMA do to help? (C. deVries, EMA)

Presentation - Information gap on safe use of medicines in pregnancy & breastfeeding (H. Sundseth, EIWH)

Presentation - Treating pregnant and breastfeeding women - The reality of clinical practice (P. Ryan, ICGP)

Presentation - How pharmacovigilance guidelines are addressing this special population (U. Liminga, Swedish Medical Products Agency)

Presentation - Covid-19 infection and medicines in pregnancy (EU PE & PV Research Network)

Presentation - How to achieve a paradigm shift in clinical research and practice (H. Dolk, euromedicat)

Multimedia

 

Session 1: Workshop on benefit risk of medicines used during pregnancy and breastfeeding

Session 2: Workshop on benefit risk of medicines used during pregnancy and breastfeeding

 

Session 3: Workshop on benefit risk of medicines used during pregnancy and breastfeeding