Report on the core data elements and analytical standards for informing HCP and patients on risks associated with exposure during pregnancy and lactation as agreed during stakeholder consultation meeting

Task 1.2: Define core data elements to allow assessment of medication utilisation and safety in pregnancy to meet regulatory requirements and standards for inclusion in product label. (M1-M12) (CHUT, GSK, ULST, SGUL, UMAN, UOSLO, Novo Nordisk, JAN, Merck, Pfizer, Lilly, NVS, EMA). This task is aimed at reaching agreement with all stakeholders including but not limited to academic, industry, clinical experts, EMA (and other regulators) on • what the core (and additional) maternal, perinatal and childhood outcome data elements are, e.g. major congenital anomalies, foetal deaths, small for gestational age, long term outcomes; • the required number of exposed pregnancies to be tested (pending medication utilisation in pregnant women); • the required analytical methods and including hypotheses to be tested, e.g. doubling risk for outcome x as compared to disease comparator; • appropriate design (e.g. comparator) that would satisfy regulatory requirements (expedited reporting; PSUR; PASS) and • quality standards for inclusion in SmPC/product label to adequately inform HCPs and patients. In collaboration with WP2, WP6 and WP7, multi-stakeholder consultation meetings will be prepared. In advance of the multi-stakeholder meetings, Novo Nordisk will lead the collection of publicly available information on these elements from literature, regulator guidance documents and product labels. Merck and CHUT will write a briefing document and GSK and CHUT will lead the discussion for WP1 during the consultation meeting. JAN and CHUT will write a report summarizing the outcome of the consultation meeting. The agreed data elements and methods will be revisited as part of Task 1.6 in the light of demonstration project results.