News and updates on the activities, initiatives and projects involving the Gianni Benzi Onlus Foundation.
Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
A new article on the evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe has been published on the Orphanet Journal of Rare Disease.
The EPTRI project has been presented at the “Partnerships in clinical trials Europe” conference in Barcelona, a big event aimed at accelerating clinical development and improving trial quality by evaluating and enhancing clinical practices and alliances.
December 1 marks the AIDS World Day, founded in 1988 to unite people worldwide in the fight against HIV, to show support for people living with HIV, and to commemorate those who have died from an AIDS-related illness. The EPIICAL project endorses this initiative, representing the largest international consortium of well-known scientists involved in the management and treatment of paediatric HIV infection.
The CloSed consortium met in Amsterdam for the final project meeting on 6 to 7 November 2018. The Dutch patient association involved in the project, VSOP (Vereniging Samenwerkende Ouder – en Patiëntenorganisaties), hosted this meeting at the Crowne Plaza Amsterdam – South.
In November and December the EPTRI project will be presented in two important events in Cyprus: the 6th International Multi-thematic Bio-Medical Congress and the 7th International Conference of the Cyprus Society of Human Genetics.
ECRIN participated in the 2018 KoNECT-MFDS International Conference in Seoul, Korea, from October 31st to November 2nd. ECRIN’s Director General, Jacques Demotes, gave a talk on “Rare diseases and paediatric clinical research networks in Europe”.
On November 29-30 in Warsaw the Gianni Benzi Foundation and the Children’s Memorial Health Institute (IPCZD) are organizing the SMART Final Open workshop “Paediatric Foresight Training Course: Current status and future changes in the European paediatric biomedical research”.
The workshop is aimed at evaluating the competences gained by the Children’s Memorial Health Institute staff and the general results of SMART project.
Laura Mangiarini (PENTA) and Carla Owen (ULIV),presented c4c in last Corbel Medical Infrastructure-Users Forum, held in Paris 15th October 2018. The Forum is designed to promote close collaboration, at the pan-EU level, between medical research communities, funding bodies, and medical research infrastructures.
How to move from a reactive to a multi-stakeholders proactive attitude
Change in Regulatory Sciences is a continuous challenging process! The challenge is to align scientific and patients’ objectives with regulatory requirements along the whole development process of health products. Moreover, all the stakeholders should be aware of the criteria by which the authorisation and access to products will be measured and decided to cover patients’ specific needs.
Key opinion leaders and experts coming from all over Europe will tackle three main topics of the XI Foresight Training Course “Change in Regulatory Sciences in the EU – How to move from a reactive to a multi-stakeholders proactive attitude”: health data supporting medicines and healthcare, also in the light of the GDPR; the new era of medical devices in Europe; rare diseases and Orphan Medicinal Product Regulation.