IMI ConcePTION
Published July 6, 2020 | Version v1
Project deliverable Open

Report describing existing coding systems, schemes and regulatory guidelines of reported medication exposed pregnancies (D2.3)

Creators

  • 1. University of KwaZulu-Natal
  • 2. Novartis
  • 3. University of Manchester
  • 4. University of Newcastle
  • 5. NovoNordisk

Description

By describing a sequence of reviews, this report aims to document current practice from which routes for improvement can be identified and implemented into future endeavours of the ConcePTION project. The reviews emphasize present regulatory frameworks regarding the collection of data on exposed pregnancies, on large-scale data collection schemes, and on how data reported through industry pharmacovigilance systems are coded and communicated to regulators.

Files

821520_ConcePTION - D2.3 Report describing existing coding systems, schemes and regulatory guidelines of reported medication use during pregnancy.pdf

Files (6.0 MB)

Additional details

Funding

ConcePTION – Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation 821520
European Commission