Report describing existing coding systems, schemes and regulatory guidelines of reported medication exposed pregnancies

Task 2.3: Core data elements required for the prospective collection and follow-up of exposed pregnancies (M1-36) (UMAN, NUTH, UOSL, LAREB, UKZN, ENTIS, NVS, Novo Nordisk, Sanofi, AbbVie, Teva and WP7 partners). This task has two key components: 1. Describe and evaluate existing coding systems, schemes and regulatory guidelines of reported medication exposed pregnancies (M1-12): Building on existing EMA and FDA regulatory guidance documents such as ICH E2B (R3) format for safety data exchange, ICH M1 MedDRA international terminology, IDMP/SPOR and ENTIS and OTIS protocols for prospective cohort collection, we will describe the requirements for spontaneous and solicited primary data collection format and coding, and the possibility and methods to map existing formats to those standards (in collaboration with WP7). Recommendations for changes to the current standards for data collection will be proposed where required following a gap analysis and assessment of content. This task will receive input from the out