Alliance Management and Regulatory Affairs in Fondazione Telethon supports Telethon Research Institutes’ scientists in navigating the regulatory landscape and fulfilling their obligations from preclinical research to clinical development, registration and market access.
What we do?
The Alliance Management and Regulatory Affairs team in Fondazione Telethon is composed of experts in the management of partnerships with pharmaceutical industries and in regulatory affairs.
The team supports Telethon Research Institutes’s scientists in progressing their preclinical and clinical research conducted in partnership with pharmaceutical companies and in navigating the regulatory landscape to develop special drugs like Orphan Medicinal products and Advanced Therapy Medicinal Products (ATMPs).
In particular, this team may support the scientists in obtaining Orphan Drug Designations (ODDs), in preparing applications and managing the procedure for Scientific Advice/Protocol Assistance at the European Medicnes Agency (EMA) and at national Competent Authorities, in fulfilling the obligation of submitting Paediatric Investigational Plans (PIPs), in exploring the opportunity to apply for PRIME scheme, the Innovation Task Force (ITF) and other development opportunities offered by EMA to academic developers. In addition, the Alliance Management and Regulatory Affairs team in Fondazione Telethon supports the clinical team in exploring opportunities to apply for Expanded Access and Early Access National programs.