Building a pregnancy pharmacovigilance model for the future: Can pregnancy data collected by ConcePTION partners be analysed using common standards developed by the ConcePTION project?

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  Gilenya pregnancy registry (Novartis) Switzerland, Siponimod pregnancy registry (Novartis) Switzerland, Teriflunomide pregnancy registries France, The Dutch Pregnancy Drug Register Netherlands, Gilenya PRIM enhanced pharmacovigilance programme Switzerland
• Data sources (types):
  Other
• Data sources (types), other:
  Spontaneous reporting system, Prospective patient-based data collection, Siponimod and ofatumumab PRIM enhanced pharmacovigilance programme (Novartis). Worldwide pregnancy enhanced pharmacovigilance programme of oral cladribine (Merck). Four Teratology Information Services (TIS) from the UK, Switzerland, and Israel will provide data for this study.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No