mariangela

About mariangela

This author has not yet filled in any details.
So far mariangela has created 56 blog entries.

CVBF-TEDDY presented the proposal for a European Paediatric Translational Research Infrastructure (EPTRI) at the 16th meeting of the ESDPPP Congress

The proposal for a European Paediatric Translational Research Infrastructure (EPTRI), developed in the framework of the European call INFRADEV-01-2017, has been presented at the 16th meeting of the European Society for Developmental Perinatal and Pediatric Pharmacology (ESDPPP) Congress, held in Belgium on 20-23 June 2017, in the section "New tools and approaches to further improve paediatric pharmacotherapy and studies ". ESDPPP is a non-profit association that puts together pharmacologists, clinicians, and scientists to promote research in developmental perinatal and paediatric pharmacology around the world. The 16th ESDPPP congress has been the occasion to highlight the urgent need to have a Research Infrastructure (RI) dedicated to Paediatrics to cover the gap in scientific research and new technologies affecting the field of paediatric medicinal products. The EPTRI proposal, coordinated by CVBF-TEDDY and submitted on March 29th, 2017, will represent a complementary RI in the context of the existing RIs to cover the current gaps in paediatric research and to enhance technology-driven paediatric research in discovery and early development phases. EPTRI will gather research groups focused on specific technical and scientific domains in five specialised Platforms and will represent a “one-stop-shop” for advice in paediatric drug development research. The project can count on a noteworthy partnership, made up of 26 partners from 19 EU/Associated countries. The evaluation of the project proposals is expected within 5 months from the submission (August 2017). Let's keep our fingers crossed! You can find the abstract submitted to the congress here: https://kuleuvencongres.be/ESDPPP2017/articles/abstracts/Bonifazi More information about EPTRI is available here : https://www.teddynetwork.net/eptri/

2017-08-11T12:54:31+00:00 11/08/2017|Categories: News|

I Level Master “Autistic Spectrum Disorders (asd): clinical, diagnostic, and therapeutic aspects from childhood and adolescence to adulthood”

Applications for the I Level Master entitled “Autistic spectrum disorder: clinical, diagnostic andtherapeutic aspects from childhood and adolescence to adulthood” are now open. The Master is promoted by the Departments of Scienze Biomediche di Base, Neuroscienze e Organi di Senso and organized by the Work Group appointed by the Rector of the University of Bari, with the scope to raising awareness of the community about the autistic spectrum disorder issues (D.R. n. 1281 del 05/05/2016). […]

2017-08-07T15:37:22+00:00 07/08/2017|Categories: News|

TEDDY collaborated in the International Paediatric Clinical Trial Day. “Helping children create lives they deserve”. San Raffaele Hospital, Milan (Italy), May 9th, 2017

  On May 9th, 2017, the International Paediatric Clinical Trial Day entitled “Helping children create lives they deserve” took place at San Raffaele Hospital in Milan. The meeting was organized by AICRO (Associazione Italiana Contract Research Organisation)  in collaboration with San Raffaele Hospital, TEDDY Network (European Network of Excellence for Paediatric Clinical Research) and INCiPiT (the Italian Network for paediatric clinical trials) and it was focused on the issues impacting on paediatric clinical research as well as the forthcoming novelties in the field. Antoinette van Dijk (AICRO) and Alessandro Aiuti (San Raffaele Hospital) for the first session, Donato Bonifazi (Consorzio per Valutazioni Biologiche e Farmacologiche), and Elisabetta Riva (San Raffaele Hospital) for the second session, were the chairs of the event. The meeting provided an overview on the current European scenario of the paediatric clinical trials, describing issues, needs and gaps existing in paediatric medicine research. Moreover, the reasons of the delays and the strategies to overcome them have been explained in detail. The participants with different backgrounds and expertise in the field of the clinical research faced the issues from different points of view (CROs, academia and industry).  Furthermore, the voice of the patients was raised, through the presentation of the innovative initiatives carried out by the YPAGs (Young Persons Advisory Groups). Here you can download the minutes of the event.

2017-08-11T14:06:07+00:00 07/08/2017|Categories: News|

The first edition of PedCRIN newsletter

PedCRIN (The Paediatric Clinical Research Infrastructure Network) is happy to present the first Edition of the quarterly Newsletters, intended to share all Network ongoing initiatives as well as papers and reports on activities involving paediatric research. […]

2017-08-07T15:06:53+00:00 07/08/2017|Categories: News|

Publication: Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

The Article “Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen” has been published on-line in Orphanet Journal of Rare Diseases 2017. The publication reports the results obtained by EuOrphan database analysis aimed to evaluate the status of orphan drugs designated for rare diseases in Europe (EU) and United States (U.S.A) up to December 2015. EuOrphan is a database that collects information on medicines for rare diseases designated and/or approved in Europe (EMA) and in the U.S.A (FDA), that has proven to be a useful tool to increase knowledge on rare diseases and facilitate research. It was created by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in the framework of a funded European IT-Technology project (eTen 510774 2003/C 118/19) and regularly updated by Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (FGB). In order to increase the availability of treatment for rare diseases, EU and US health authorities have adopted specific pieces of legislation including incentives to companies developing treatments or diagnostics for rare diseases Published data show that notwithstanding these incentives, the number of medicines for rare diseases is still limited, and this is more evident in several therapeutic areas. With reference to paediatrics, published data demonstrated that despite of the interest and the need for drugs approved for children, about half of drugs approved in the EU and US for a rare disease affecting children lack of a paediatric indication and this situation is most serious for younger children, especially neonates. Authors conclude that joint efforts and cooperation between EU and US seem to be the key to speed up the development and marketing of drugs for rare [...]

2017-08-11T13:51:09+00:00 07/08/2017|Categories: News|