Conducting clinical trials is an extremely complex undertaking in one country let alone one involving multiple countries. In most cases, the trials are conducted in multiple countries due to strategic reasons in order to obtain regulatory approvals for the drug product or device under study....

The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we...

This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research...