Network identification

PURI

https://redirect.ema.europa.eu/resource/2221140

Network ID

2221140

Network name and Acronym

Organization of Teratology Information Specialists (OTIS) Network

Network website

ENCePP partner

No

Institutions that are part of this network

Pharmakovigilanzzentrum Embryonaltoxikologie (Embryotox Berlin), Charité-Universitätsmedizin
Teratology Information Service, Helsinki (TIS Helsinki), HUSLAB

Studies conducted by the network

An OTIS/MotherToBaby Pregnancy Registry-based observational cohort study to evaluate pregnancy and infant outcomes in individuals exposed to Boostrix as of the 1st day of the 27th week of gestation in the US (EPI-PERTUSSIS-075 VS US PR 219588)
Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study (20150338)
Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry (Kesimpta Pregnancy Registry)
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated with Mayzent (siponimod): An OTIS Observational Pregnancy Surveillance Study
Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
The Benralizumab Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study
The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy (200870 NPSS (Nucala Pregnancy Surveillance Study))