Harmonized Safety Monitoring of Immunization Pregnancy
International Consensus Conference

March 29-30, 2016
National Institutes of Health
Bethesda, Maryland, USA


  • The aim of this conference is to highlight progress in harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach.


  • To discuss new safety data from immunization in pregnancy studies

  • To identify converging stakeholder needs and requirements for high quality data

  • To review new standards and tools for safety monitoring, including terminology

  • To build consensus on best practice guidance for monitoring vaccine safety in pregnancy


  • Shared understanding of the challenges of monitoring immunization in pregnancy

  • Shared understanding of potential solutions for a collaborative way forward

  • Consensus on the need for a globally concerted approach

  • Recommendations for a road map towards optimal safety data based on a globally harmonized approach

This conference is inspired by the work performed within the GAIA project by partners and volunteers worldwide. This meeting will bring together regulators, scientists, academia and industry experts to help resolve existing challenges of safety monitoring of immunization in pregnancy and to reach conclusions that will be valuable to a globally concerted approach.

Dear Colleagues,
Dear Friends,

I am truly grateful for everyones outstanding contributions to the productive International Consensus Conference on Harmonized Safety Monitoring of Immunization in Pregnancy in Bethesda March 29-30, 2016. We are pleased to share the videos and some of the conference materials with you on this web-page. Thanks to the close collaboration of NIH, IABS, and SYNAPSE, and thanks to the agreement of all speakers, we can make this valuable material available for both the meeting participants and everyone not able to attend the meeting in person.

We are working on the meeting report, which will be published in the Journal Biologicals for future reference in the next months.


Jan Bonhoeffer

On behalf of the Scientific Committee

Download the speaker presentations via this link : Speaker Presentations

Watch the complete conference (you can jump from one session to the other by using the “previous” and “next” buttons):

Thank You to our Partners for their strong support of the
Harmonized Safety Monitoring of Immunization in Pregnancy
International Consensus Conference