Regulatory Affairs in Fondazione Telethon supports Telethon Research Institutes’s scientists navigating the regulatory landscape and fulfilling their obligations from preclinical research to clinical development, registration and market access.
What we do?
Regulatory Affairs in Fondazione Telethon is a team of people expert in the Regulatory Affairs who supports Telethon Research Institutes’s scientists navigating the regulatory landscape to develop special drugs like Orphan Medicinal products and Advance Therapy Medicinal Product (ATMP).
In particular, this team may support the scientists to obtain Orphan Drug Designation (ODD), to prepare application and manage the procedure for Scientific Advice/Protocol Assistance at EMA and at National level with National Competent Authorities, to fulfil the obligation of Paediatric Investigational Plan (PIP), to explore the opportunity for applying for PRIME scheme, Innovation Task Force (ITF) and other development opportunities offered by EMA to the academic developers. In addition, Regulatory Affairs in Fondazione Telethon supports clinical team to explore opportunities to apply for Expanded Access and Early Access National programs.