REPURPOSING TO COVER UNMET NEEDS: THE CURRENT SCENARIO IN EUROPE AND THE PROPOSED CHANGES TO THE PHARMACEUTICAL LEGISLATION

18 December, 2023
Online + Università degli Studi di Bari Dipartimento di Farmacia, via Orabona 4 – Bari (Italy)

The XVI Foresight Training Course was organised by Fondazione Gianni Benzi in collaboration with Università degli Studi di Bari Aldo Moro.

The event gathered over 170 participants, including representatives from European institutions, academia, industry, and patient organisations. Experts discussed drug repurposing as a promising and dynamic strategy for addressing unmet therapeutic needs, particularly in paediatric and rare disease contexts.

Key topics included current and proposed European regulatory frameworks for research, development, and marketing authorisation; industry and academic approaches to repurposing; commercial strategies; the need for tailored formulations; and the use of tools like in-silico modelling and real-world data. The potential impact of proposed changes to the pharmaceutical legislation under Articles 48 and 75 of the new regulation was also explored.

The course also featured contributions from patient representatives, who highlighted the importance of involving patients in repurposing processes to better address their specific needs and concerns.

The event successfully facilitated knowledge exchange and sparked meaningful discussions among all stakeholders involved in the repurposing ecosystem.

Additional details in the agenda.