News & Events

Paediatric Devices survey. Your help is needed! Share your experiences of using devices to take medicines

The European Paediatric Formulation Initiative (EuPFI) works to improve the preparation of better and safer medicines for children. One area they are interested in is the “gadgets” or devices (e.g. measuring spoons, dosing cups, inhalers) that are used to help patients take their medicines. It is important that these devices are used properly to make sure the correct dose of medicine is taken. The EuPFI devices workstream have designed a short questionnaire to understand what devices you or your child 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) supports the mainland Europe dissemination and review of survey questions by the young members of Albanian, Italian and Spanish YPAGs (Young Persons Advisory Groups), respectively KIDS Albania, KIDS Bari and KIDS Barcelona, to guarantee that the language is comprehensible and children-friendly. The survey is addressed to boys and girls between 10 to 18 years of age and their parents. It will take approximately 10-15 minutes to be completed. The survey is available in the following languages: English, Italian, Albanian and Spanish: Albanian: Paediatric Devices Survey KIDS Albania   Italian: Paediatric Devices Survey KIDS Bari Spanish: Paediatric Devices Survey KIDS Barcelona English: Paediatric Devices Survey English  

2020-06-24T07:40:34+00:00 19/06/2020|Categories: News & Events|

SAVE THE DATE – Webinar AICRO: The concept of “vigilance” in clinical studies widens the boundaries: from the experience on the drug to the medical device

On June 25, 2020, from 11.00 to 13.00, the AICRO training webinar will be held. The webinar is entitled: The concept of "vigilance" in clinical studies broadens the boundaries: from experience on the drug to the medical device. The regulatory background, language and methods of action: compared experiences. It will be an interactive seminar, although in webinar mode, where the requirements of pharmacovigilance in the context of clinical trials will be addressed, to then discuss the imminent need to adapt the "surveillance" activity also to the medical devices field. The speakers will refer to the current legislation and share direct experiences with the participants, offering a multifaceted panorama for different actors: CROs, Sponsors, Clinical Trial Centers. Mariagrazia Felisi, Clinical Research Director at Consorzio per Valutazioni Biologiche e Farmacologiche, will be among the speakers of the webinar and will provide an overview of regulatory landscape on the drug, describing the role of the User in Eudravigilance and the delegation process. More information on registration modalities and the agenda of the event is available at this link.

2020-06-17T16:30:07+00:00 17/06/2020|Categories: News & Events|

Clinical Trials Digital Week

On 2020 June 1-4, the event “Clinical Trial Digital Week” took place as a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for operational challenges and responding to a pandemic, partnerships, outsourcing and operations, technology in clinical trials, and clinical innovation. This edition foresaw the participation of Mariangela Lupo, Communication and Patient Advocacy Manager at TEDDY European Network of Excellence for Paediatric Research, member of CVBF. She held the webinar entitled “The Patient Centricity Effect – How It benefits Patients, Sites and Sponsors – Practical Cases From Paediatric Studies”. The webinar provided practical examples on how to involve children in clinical trials. A child-friendly approach is necessary not only in the daily clinical practice, but throughout the research and development process, from setting research priorities, involvement in research design and planning, research conduct through to dissemination and communicating research findings. The recording of the webinar is available at this link.

2020-06-17T15:59:58+00:00 17/06/2020|Categories: News & Events|

New COVID-19 guide for youths

The Smithsonian Science Education Center, in collaboration with the World Health Organization (WHO) and the InterAcademy Partnership (IAP) has developed “COVID-19! How can I protect myself and others?” a new rapid-response guide for youth ages 8–17. The guide, which is based on the UN Sustainable Development Goals, aims to help young people understand the scientific and social aspects of COVID-19 as well as help them take actions to keep themselves, their families and communities safe. Through a set of seven cohesive student-led tasks, participants engage in the activities to answer questions previously defined by their peers. The questions explore the impact of COVID-19 on the world, how to practice hand and respiratory hygiene and physical distancing, and how to research more information about COVID-19. The final task teaches youth how they can take action on the new scientific knowledge they learn to improve their health and the health of others. Each task is designed to be completed at home. The guide includes updated research, activities, quotes from scientists and frontline public health officials, and physical and emotional safety tips on COVID-19. It also integrates inquiry-based science education with social and emotional learning and civic engagement. This was not the only initiatives dedicated to children aimed to explain how to manage the COVID-19 emergency. The conect4children network (c4c) brought together a range of trusted resources, in a variety of European languages and formats, to empower and enable children and their families to access necessary information on COVID-19. These resources can be accessed at this link.

2020-06-17T15:47:32+00:00 17/06/2020|Categories: News & Events|

EPTRI toolkit for patients and families

In the framework of EPTRI (European Paediatric Translational Research Infrastructure) a toolkit for patients has been developed to explain what the translational research is as well as to provide information about basic research and its models and resources. Providing informative material about the objectives, the goals and the resources used in the paediatric translational research is an important strategy to train empowered young patients and boost their engagement in the research and development process. The script of the video was revised by English-speaking children as well as by the youths of the Italian, Albanian and Spanish Young Persons Advisory Groups (YPAGs), respectively KIDS Bari, KIDS Albania and KIDS Barcelona to have a final children-friendly version using a comprehensible language for paediatric patients. The video will be translated in different European languages among which Italian, Albanian and Spanish and will be available soon on the official EPTRI website.

2020-06-17T15:16:06+00:00 17/06/2020|Categories: News & Events|

Special Issue “Scientific Highlights in the First European Paediatric Translational Research Infrastructure Open Meeting” on Pharmaceutics

The EPTRI Open Meeting on April 2-3 April 2020, due to Covid-19 outbreak, was run online. In occasion of this event the Special Issue entitled "Scientific Highlights in the First European Paediatric Translational Research Infrastructure Open Meeting" has been created on Pharmaceutics, an Open Access journal. EPTRI Work package 8 co-Leader Nunzio Denora (University of Bari, member of CVBF) is the Guest Editor of the Special Issue. Any original research articles, reviews, opinion papers, editorials or short communications are welcome on the following topics related to EPTRI: paediatric medicines drug targets and methods of identification; advanced cellular/in vitro models for paediatric drug targeting; paediatric formulations and toxicology of drugs; drug delivery design in paediatrics; translational research EPTRI (European Paediatric Translational Research Infrastructure) is an EU funded project coordinated by CVBF and aimed to design the framework for a new infrastructure dedicated to paediatric research that will work to accelerate a technology-driven paediatric medicines development processes from drug discovery and early development phases to be translated into clinical phases and medicines uses. Before the meeting the launch of a call for abstracts was foreseen, giving to the researchers the possibility to express their interest to participate to EPTRI. The recordings of the event, the presentations as well as the videos have been published on the EPTRI YouTube channel and on the EPTRI website in the dedicated page of the EPTRI Open meeting at this link.

2020-06-17T14:51:41+00:00 17/06/2020|Categories: News & Events|

CVBF collaborated in the launch of a new video on children, young people and families’ involvement in c4c Network

Patient’s involvement in paediatric clinical trials is recognized as an important component at European and International level and an essential contribution to paediatric clinical research. In order to guarantee that paediatric patients and their carers are effectively involved on the basis of their health conditions and personal experiences, it is necessary that they are well informed and trained on clinical research themes and activities they can perform in the scientific projects. For this reason, Consorzio per Valutazioni Biologiche e Farmacologiche within the conect4children project (c4c) collaborated and coordinated the development and launch of the new video “c4c - We want to hear from young people!”. This video is addressed to members of Young People Advisory Groups (YPAGs), paediatric patients and their families and explains the activities they can be involved in within the c4c project. c4c wants to provide every paediatric patient with a voice, placing them at the centre, and assigning them an active role in the development of the different clinical trials carried out by c4c. The video is available at this link.

2020-06-17T13:55:41+00:00 16/06/2020|Categories: News & Events|

CVBF lead the implementation of c4c short courses in Trial Start Up and Monitoring

We are pleased to inform you that CVBF coordinated the preparation of the first edition of the Trial Start up and Monitoring online Training Courses in the conect4children (c4c) project. These two courses were launched on 25 May 2020 and were available for all clinical site staff and healthcare professionals involved in the c4c funded clinical trials. The courses provided general knowledge on activities to start paediatric clinical trials, as well as good-quality monitoring of paediatric clinical trials in the experimental sites. In line with the international and European standards, such as ICH E6 Good Clinical Practice (R2) taking into account the guidelines specific for children (e.g., Ethical considerations for clinical trials on medicinal products conducted with minors and ICH E11 Harmonised tripartite guideline, and clinical investigation of medicinal products in the paediatric population (R1)). The Trial Start up course provided information on how to plan trial start up, Trial Master File set up, study submission package and administrative procedures. In addition, qualifications and site initiation visits were addressed. In the Monitoring course, the role of the monitor was described, site staff responsibilities in clinical trial monitoring as well as monitoring procedures, monitoring plan and SOPs were outlined.

2020-06-16T13:32:14+00:00 16/06/2020|Categories: News & Events|

Live Webinar “The power of innovation for the relaunch of Mezzogiorno. The pharmaceutical supply chain in facing the Covid-19 challange”

On 17 June 2020 at 11:00, the webinar “The power of innovation for the relaunch of the South of Italy. The pharmaceutical supply chain in facing the Covid-19 challange” will be organised by the Center “Studi e Ricerche per il Mezzogiorno” (SRM) linked to the Group Intesa San Paolo and in collaboration with Farmindustria – Associazione delle imprese del farmaco. The webinar will provide the occasion to discuss the new strategies of high-quality training and research as well as innovation and industrial value as competitiveness factors needed to guide the economic recovery. The event will foresee the intervention of the Minister of University and Research, Gaetano Manfredi. A special session will be dedicated to the pharmaceutical supply chain (in particular in the Southern Regions) that represents one of the sectors that can drive the economic recovery after the pandemic Data, analyzes and new economic scenarios will be presented by SRM, which will illustrate the results of the study on the pharmaceutical supply chain in the facing the Covid-19 challenge. At this link is possible to register.

2020-06-16T12:03:36+00:00 16/06/2020|Categories: News & Events|

EMA Guidance for medicine developers and companies on COVID-19

The European Medicines Agency (EMA) released a guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. The overall aim is to accelerate and simplify the procedures for the development of COVID-19 treatments and vaccines, providing a guide in every step of the regulatory pathway as well as ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions. EMA encourages the scientific community and companies to join the efforts in this sense and invite them to contact EMA as soon as possible to discuss their strategy for evidence-generation. The guideline is available at this link.

2020-06-15T16:53:38+00:00 15/06/2020|Categories: News & Events|