Webinar | November 10, 2016

Developing Innovative Approaches To Postmarketing Safety Data Collection In Pregnant Women

Source: UBC

Generating real-world evidence is essential to uncovering the potential effects a product may have on pregnancy outcomes, particularly for women of childbearing age who require chronic therapy for diabetes, depression, epilepsy, asthma and more.

Understanding key regulatory guidance points and the most vital considerations in pregnancy registry design will allow you to efficiently create and summarize the data needed for regulatory reporting.

This webinar covers:

  • The relationship between prescription drug use and birth outcome information
  • The guidelines for when it is appropriate to conduct a pregnancy registry from EMA and FDA
  • How to implement processes that ensure patients receive appropriate follow-up communications to ensure reporting success
  • How well-designed and documented pregnancy exposure registries hold promise of allowing prescribers to best advise their patients and help pregnant women make better-informed decisions regarding the best therapeutic choices during pregnancy