WHAT'S NEW Highlights on our activities and initiatives
NEWBORN SCREENING FOR SICKLE CELL DISEASE IN AFRICA
Within the ARISE project, we are supporting the implementation of the Newborn Screening for Sickle Cell Disease (SCD) in African countries such as Nigeria, Kenya and Zambia. As part of the ongoing American Society of Hematology’s Consortium on Newborn Screening in Africa (CONSA), the first newborn screening for SCD and early therapeutic intervention programme has started in Nigeria and Zambia.
More detailed information about these programmes can be found in thearticle “Newborn screening for sickle cell disease in Africa” published on the Lancet Haematology journal.
A NEW PAPER ON ETHICAL AND PROCEDURAL ISSUES FOR PAEDIATRIC CLINICAL TRIALS PUBLISHED ON THE BMC MEDICAL ETHICS
The manuscript “Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project” has been published on the BMC Medical Ethics journal.
Viviana Giannuzzi, researcher from Fondazione Benzi coordinated this work that aims to evaluate the impact of the different local and national rules and procedures and of their complexity on the paediatric trial authorisation process in different European and non-European countries from the preparation of submission package to the release of authorisation and approval.
The PedCRIN final event “Fostering International Paediatric Clinical Research” was held on June 16th, 2021.
It was focused on the challenges of paediatric multinational clinical trials. Experts from the consortium presented the main outcomes of the project and discussed the supporting tools, methods, identified gaps and future initiatives and collaborations.
Lucia Ruggieri from Fondazione Benzi took part in the event providing a contribution on the results of the PedCRIN survey aimed to capture the needs of stakeholders involved in paediatric clinical research.
ACROSS THE WORLD Updates and latest news across the world
REGULATION ON MEDICAL DEVICES NOW APPLICABLE IN EUROPE
Regulation (EU) 2017/745 on medical devicesbecomes applicable in the European Union.
The Medical Device Regulation (MDR) entered into force in 2017 replacing the existing Directives for medical devices (93/42/EECand90/385/EEC). It aims to ensure the smooth functioning of the internal market as regards medical devices, for a high-level protection of health for patients and users.
At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns related to such products.
FIRST COVID-19 VACCINE APPROVED FOR CHILDREN AGED 12 TO 15 IN EUROPE
The Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA) has recommended granting an extension of indication for the COVID-19 vaccineComirnaty® to include use in children aged 12 to 15.
The effects of Comirnaty® in children were investigated in 2260 children aged 12 to 15 years.
The trial showed that the immune response to Comirnaty® in this group was comparable to the immune response in the 16 to 25 age group, as measured by the level of antibodies against SARS-CoV-2. In this study, the vaccine was 100% effective at preventing COVID-19. The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above.
DONATE THE 5×1000 CONTRIBUTION TO FONDAZIONE GIANNI BENZI ONLUS
Donate the 5x1000 contribution to Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus!
Just fill in the section "Financing scientific research and universities" by entering the tax code 933 478 007 29!
Your contribution can help us developing our activities.
The future is now! Thank you!
The manuscript “Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project” has been published on the BMC Medical Ethics journal.
