The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.

In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres.

Economic burden of Systemic Lupus Erythematosus and Lupus Nephritis in France: a nation-wide population-based study using the French medico-administrative (SNDS) claims database.

Objectives: Data on the economic consequences of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) are scarce in Europe. We aimed to estimate the total direct costs attributable to SLE and LN in France, at the nation-wide level.

Methods: Patients with SLE and LN were identified in the French nation-wide health insurance database (SNDS).

COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy.

The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire.

Neurodevelopmental outcomes after prenatal exposure to lamotrigine monotherapy in women with epilepsy: a systematic review and meta-analysis.

Background: Lamotrigine has become one of the most commonly prescribed antiseizure medications (ASM) in epileptic women during pregnancy and therefore requires regular updates regarding its safety. The aim of this study was to estimate the association between in utero exposure to lamotrigine monotherapy and the occurrence of neurodevelopmental outcomes.

Methods: All comparative studies assessing the occurrence of neurodevelopmental outcomes after epilepsy-indicated lamotrigine monotherapy exposure during pregnancy were searched.

Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.

Background: Knowledge about the risks of drugs during pregnancy is continuously evolving due to the frequent publication of a large number of epidemiological studies. Systematic reviews and meta-analyses therefore need to be regularly updated to reflect these advances. To improve dissemination of this updated information, we developed an initiative of real-time full-scale living meta-analyses relying on an open online dissemination platform ( www.