ABSTRACT
Regulatory affairs specialists are increasingly taking senior strategic roles and need to have a comprehensive understanding not only of the technical and legal issues but also of management and strategic planning. The Organization for Professionals in Regulatory Affairs (TOPRA) is the professional membership organisation for individuals working in healthcare regulatory affairs. The TOPRA Medical Devices Special Interest group is an international network of TOPRA members who can communicate online in a closed environment and support each other. TOPRA provides members with top-quality, relevant support with a particular focus on European matters. There is no doubt that the regulatory environment in the European Union is entering a phase of seismic change. Meanwhile new aspects and technologies such as healthcare software continue to challenge both the industry and regulators. TOPRA exists to assist with the challenges for regulatory professionals in the medtech as well as the pharmaceutical and veterinary medicines sectors.
