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Newsletter no. 11 - June 2021

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 the
 article “Newborn screening for sickle cell disease in Africapublished on the Lancet Haematology journal.

Visit the ARISE website - Read the full article 

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 projecthas 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.

Discover more - Read the full article

PedCRIN FINAL EVENT

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.

Discover more - Visit PedCRIN website

ACROSS THE WORLD
Updates and latest news across the world

REGULATION ON MEDICAL DEVICES NOW APPLICABLE IN EUROPE

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union.
The Medical Device Regulation (MDR) entered into force in 2017 replacing the existing Directives for medical devices
(93/42/EEC and 90/385/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.

Discover more - Consult the Regulation (EU) 2017/745

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 vaccine Comirnaty® 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.

 

SUPPORT US

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!

Discover more - Visit our website

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