18th August 2020

Newsletter August 2020

EPTRI Stakeholders Roundtable was held on July: what are the future strategies of the paediatric research?

On 9 July 2020 the EPTRI Stakeholders Roundtable was held online. The virtual meeting provided the possibility to discuss about the future strategies of collaboration with other biomedical research infrastructures and European initiatives and networks relevant for paediatric research.

In the framework the c4c IMI2 funded project (pan European paediatric clinical trials network) cASPerCF study will be carried out. CVBF is responsible for Sites Assessment, Data Management, Study Monitoring, Trial Master File Preparation and Maintenance.

The EuPFI devices workstream have designed a short questionnaire to understand what devices children use and how easy they are to handle, to help to find ways of making the devices more user friendly. EPTRI (European Paediatric Translational Research Infrastructure) promoted the review of the questions by the young members of Albanian, Italian and Spanish YPAGs (Young Persons Advisory Groups) and supports the dissemination of the survey.

The European Medicines Agency (EMA) released an Expert Group Recommendation on the content of Lay Summaries of clinical study results from commercial and non-commercial sponsors. A group of 60 participants from EU and US stakeholders under the leadership of The European Forum for Good Clinical Practice (EFGCP) and The European Federation of Pharmaceutical Industries and Associations (EFPIA) has created the “Roadmap Initiative to Good Lay Summary Practices”.

Since 2009 CVBF has been acting as no profit Sponsor and Clinical Research Organisation (CRO) and it is ready to provide its expertise in clinical trials at national and international level, with a specific attention to research driven, innovative design and small population studies. Another important goal has been just reached by CVBF, successfully overcoming 3 days of Good Clinical Practice (GCP) Audit by the Italian Medicines Agency (AIFA).

EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners.

We are glad to inform you that Consorzio per Valutazioni Biologiche e Farmacologiche will provide its contribution in the fight against COVID-19 emergency. It was recently been entrusted by UPMC – University of Pittsburgh Medical Center with the two studies on COVID-19 which aim to test two vaccines.

The European Commission is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. CVBF as coordinator of the European Paediatric Translational Research Infrastructure (EPTRI) provided its comments underlining the necessity to stress new adequate health policies promoting the development and the access to safe and efficacious medicines for children.