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News
News and updates on the activities, initiatives and projects involving the Fondazione Gianni Benzi Onlus.

EMA/EUnetHTA 21 Joint Scientific Consultation
A guidance was published in September 2022 to describe the process, timelines and actions for each party undertaking a parallel EMA/EUnetHTA 21 Joint Scientific Consultation.

Recommendation paper on decentralised elements in clinical trials
In December 2022, the European Commission, the Heads of Medicines Agencies and the European Medicines Agency released a Recommendation paper on decentralised elements in clinical trials based on the experience gained from the COVID-19 pandemic

EU Guideline on orphan applications
In December 2022, the European Commission released a Guideline on the applications for orphan designation.

XV Foresight Training Course: research and innovation
The XV Foresight Training Course “Boosting research and innovation in a changing regulatory framework”, organised by Fondazione Gianni Benzi in close cooperation with Università degli Studi di Bari Aldo Moro, was held on 15-16 December 2022 in Bari and online.

Joint Transnational Call 2023
The EJP RD Joint Transnational Call, a funding opportunity for research projects, will be launched on December 12th.

SAVE THE DATE – XV Foresight Training Course (15-16 December 2022, Bari)
The XV Foresight Training Course “Boosting research and innovation in a changing regulatory framework” will run as a hybrid meeting on 15-16 December 2022 in Bari at Sala Leogrande (Ex Palazzo delle Poste, piazza Cesare Battisti 1) and online.

FGB at the EJP RD General Assembly and Consortium Meeting 2022
The annual General Assembly and Consortium Meeting of the European Joint Programme on Rare Diseases – EJP RD was held in September 2022 in Porto, Portugal.

SAVE THE DATE: ITHANET virtual information day
The ITHANET virtual information day will be held virtually on September 29th 14:00 – 17:00 GMT+3.

IRDiRC Announces The Creation of Regulatory Science Committee to Tackle Regulatory Challenges in Rare Disease Research
IRDiRC announced the formation of the Regulatory Science Committee.

SAVE THE DATE – Malattia di Lafora: from research to patients’ rights
The roundtable “Malattia di Lafora: dalla ricerca di farmaci ai diritti dei pazienti – Per una stretta cooperazione tra ricerca e assistenza” will be held on September, 12th in Bari.