December 16th, 2018

Newsletter December 2018

News

Donato Bonifazi has been named chair of the EUCROF Events & Training Working Group

The European CRO Federation (EUCROF) is an organisation founded in 2005 with the aim to promote high quality clinical research in Europe, favouring the exchange of information and encouraging a close relationship between the national member associations and regulatory bodies, pharmaceutical-biotechnology industry and the medical research community. Among the initiatives promoted by EUCROF, the activities performed within its working groups provide a good occasion of discussion on specific areas of interest in the clinical research field.

KIDS Bari and Albania contributed to the EnprEMA survey on “Factors Impacting Paediatric Clinical Studies Preparedness” during their meetings on November

KIDS Bari and Albania, the first Young Advisory Groups in Italy and Albania, promoted by CVBF in collaboration with the TEDDY Network, keep on with their advocacy and patient engagement activities, this time participating to the survey on the “Factors Impacting Paediatric Clinical Studies Preparedness” developed by the Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) Working Group on Clinical Trial Preparedness.

SPASD Project: a new e-learning course dedicated to school teachers willbe delivered in January

SPASD (Strengthening the Capacity of Professionals Working in Schools with Children and Young People with Autism Spectrum Disorder) is a project started in 2017 and funded in the framework of the Erasmus+, EU’s programme dedicated to support education, training, youth and sport in Europe.
The project foresees the development of an e-learning course aimed to increase the expertise of teachers working with ASD (Autism Spectrum Disorder) students or who want to increase their skills in providing high quality and inclusive classroom teaching.

CVBF will be involved in the forthcoming EU funded project “European Joint Programme on Rare Diseasea”, starting on January 2019

We are very pleased to announce that Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) will participate as Partner in the new Co-fund action, the European Joint Programme on Rare Diseases (EJP RD). The main objective of the programme is to create a research and innovation pipeline “from bench to bedside” ensuring rapid translation of research results into clinical applications and uptake in healthcare for the benefit of patients.

28-29 November the SMART Open workshop – Paediatric Foresight Training Course took place in Warsaw

The final SMART Open workshop – Paediatric Foresight Training Course, took place in Warsaw on 29 and 30 November 2018. The workshop was realised in the framework of SMART – Small Medicines Advanced Research Training, a EU funded project coordinated by the Instytut Pomnik Centrum Zdrowia Dziecka (IPCZD – Poland) and aimed to raise IPCZD staff’s research profile and increase capacity in providing innovative paediatric research methods. Within the project, a specific training programme has been developed, including the organisation of staff exchanges, face to face courses and summer schools.

PROMISE project: the first patients have been recruited

In the framework of the PROMISE (Drugs for PaediatRic MultIple SclErosis) project, a 36-month multi-centre randomized interventional pragmatic trial, the first two paediatric patients have been recruited at the University Hospital Policlinico of Bari. The children affected by multiple sclerosis will be part of the study aimed to evaluate the effectiveness and safety of glatiramer-acetate (GA) compared to interferon-beta (IFN-beta).

FUTURE EVENTS

SAVE THE DATE
December 2018, 18-19

7° Network Governing Council Meeting and 4° Investigators Meeting
On 18th and 19th December 2018, the 7° Network Governing Council Meeting and the 4° Investigators Meeting of the NeoVanc project will be held in Athens at the Collaborative Center for Clinical Epidemiology and Outcomes Research – CLEO. The meeting will be aimed to provide an update on the project progress and in particular on the NeoVanc study (eg statistical plan, preliminary PK analysis).

SAVE THE DATE
January 2019, 10

A new EPTRI Webinar: “Social media to communicate science and r&d projects”
EPTRI (European Paediatric Translational Research Infrastructure) has designed a new webinar aimed to provide information on the different strategies to use social media as channel for science communication. The webinar is addressed to researchers, institutions, clinicians and people interested in science and institutional communication and has the scope to show how to choose the adequate social media channel in order to reach the desired target and disseminate scientific topics through these platforms.¢$

Across the Europe

EMA Consultation: draft qualification opinion on eSource Direct Data Capture (DDC)

The European Medicines Agency (EMA) has released for public consultation a draft Qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The document is intended to give information about the regulatory acceptability to use an eSource Direct Data Capture in clinical trials conducted to support a Marketing Authorisation Application for a medicine.

EMA and DG SANTE have published a joint action plan to support the development of medicines for children in Europe

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published a joint action plan to support the development of medicines for children in Europe. The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation.