Research conducted on gestating women globally during trials

The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.

The InsurTechs in Brazil: a legal and regulatory analysis

The insurance industry is facing an unprecedented wave of disruption. While all stakeholders welcome the new insurance products and the improved consumer experience resulting from technological advances, jurists face a number of challenges. In particular, it could be asked: is the current Brazilian legal system able to regulate InsurTechs adequately? The following paper will analyze the legal and regulatory aspects of the operation of companies characterized as “InsurTechs” and how they are functioning in Brazil. To this aim, the following will be addressed: (i) the concept of InsurTech; (ii) the Brazilian regulatory authority’s Regulatory Sandbox approach and; (iii) The functioning of InsurTechs in Brazil.