CONSORTIUM FOR DEVELOPING REGULATORY CAPACITY FOR CLINICAL TRIALS USING GENE THERAPY PRODUCTS AND STRENGTHENING PHARMACOVIGILANCE IN THE CONDUCT OF CLINICAL TRIALS IN EAST AFRICA

Informazioni relative al progetto

CAPACITY 2023

ID dell’accordo di sovvenzione: 101145599

DOI

10.3030/101145599

Data della firma CE 22 Marzo 2024

Data di avvio 1 Aprile 2024

Data di completamento 31 Marzo 2027

Finanziato da

• Health

Costo totale

€ 999 315,35

Contributo UE

€ 999 315,35

Coordinato da

UNIVERSIDADE DE COIMBRA
Portugal

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Documents, reports (7)

Project launch report

Project Launch meeting. Launch of the project website.

Obtaining ethical approval of the proposed study

Submission for ethical approval s and administrative clearance

Researchers, Clinicians & NRA personnel sensitized and trained on aspects of research using gene therapy products.

Workshops, webinars and stakeholders meetings

Plan for the exploitation and dissemination of results including communication activities

Exploitation and dissemination Plan

Short term trainings on PV in Clinical Trials

Enrol 5 members from NDA and UNCST in medium- and short-term trainings on Pharmacovigilance delivered Eu2p consortium

Results Framework

Monitoring and evaluation Framework for the grant implementation process

Set up of Project website and other publicity materials such as (flyers, posters, brochures)

Sent up of Project information on institutional website and making project publicity Materials to share with colleagues and associations the grant and activities

Data Management Plan (1)

Data management plan

Development of the Data Management Plan, this also provides details on how data from the grant will be disseminated.

Pubblicazioni

Peer reviewed articles (2)

Progression of biological markers in spinocerebellar ataxia type 3: longitudinal analysis of prospective data from the ESMI cohort

Autori: Moritz Berger; Hector Garcia-Moreno; Mónica Ferreira; Jeannette Hubener-Schmid; Tamara Schaprian; Philipp Wegner; Tim Elter; Kennet M. Teichmann; Magda M. Santana; Marcus Grobe-Einsler; Demet Oender; Berkan S.C. Koyak; Sarah Bernsen; Luís Pereira de Almeida; Patrick Silva; Joana Afonso Ribeiro; Inês Cunha; Cristina Gonzalez-Robles; Shamsher Khan; Amanda Heslegrave; Henrik Zetterberg; Manuela Lima; Mafalda Raposo; Ana F. Ferreira; João Vasconcelos; Bart P. van de Warrenburg; Judith van Gaalen; Teije H. van Prooije; Jeroen de Vries; Ludger Schols; Olaf Riess; Matthis Synofzik; Dagmar Timmann; Andreas Thieme; Friedrich Erdlenbruch; Jon Infante; Ana L. Pelayo-Negro; Leire Manrique; Kathrin Reetz; Imis Dogan; Gulin Oz; James M. Joers; Khalafalla Bushara; Chiadikaobi Onyike; Michal Povazan; Heike Jacobi; Jeremy D. Schmahmann; Eva-Maria Ratai; Matthias Schmid; Paola Giunti; Thomas Klockgether; Jennifer Faber
Pubblicato in: The Lancet Regional Health - Europe, Numero 55, 2025, ISSN 2666-7762
Editore: Elsevier Ltd
DOI: 10.1016/J.LANEPE.2025.101339

Circadian rhythms are disrupted in patients and preclinical models of Machado-Joseph disease

Autori: Rodrigo F N Ribeiro, Dina Pereira, Sara M Lopes, Tiago Reis, Patrick Silva, Diana D Lobo, Laetitia S Gaspar, João Durães, Ana Rita Fernandes, Marisa Ferreira-Marques, Catarina Carvalhas-Almeida, João Peça, Ana Rita Álvaro, Isabel Santana, Magda M Santana, Maria Manuel C Silva, Luís Pereira de Almeida, Cláudia Cavadas
Pubblicato in: Brain, Numero 148, 2025, ISSN 0006-8950
Editore: Oxford University Press (OUP)
DOI: 10.1093/BRAIN/AWAF199