Change in Regulatory Sciences is a continuous challenging process! The challenge is to align scientific and patients’ objectives with regulatory requirements along the whole development process of health products.
Moreover, all the stakeholders should be aware of the criteria by which the authorisation and access to products will be measured and decided to cover patients’ specific needs. To ensure such an alignment, it is time to moving from a reactive regulation to a proactive involvement of all the involved parties, including users as well as producers.
This course is aimed at involving and networking people to properly understand the many novelties of the EU system and contributing to their implementation to anticipate good medicines and other products for human health and wellbeing on the market. The present Course will discuss the EU Pharmaceutical System novelties, with special focuses on three main topics. In addition, an initiative to set up a Regulatory Network will be presented.