European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



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STAND4Kids - Supporting Pediatrics Trials in Portugal

Number of peer reviewed publications in the last 5 years 5 Turner, Mark A., Heidrun Hildebrand, Ricardo M. Fernandes, Saskia N. de Wildt, Fenna Mahler, Regis Hankard, Rebecca Leary, et al. “The Conect4children (C4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children.” Pharmaceutical Medicine 35, no. 2 (March 2021): 71–79. https://doi.org/10.1007/s40290-020-00373-6. Mantha, Olivier L., Florence Flamein, Mark A. Turner, Ricardo M. Fernandes, and Regis Hankard. “Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time.” The Journal of Pediatrics 239 (December 2021): 67-73.e3. https://doi.org/10.1016/j.jpeds.2021.08.028. Degraeuwe, Eva, Tessa van der Geest, Laura Persijn, Lieve Nuytinck, Ann Raes, Mark Turner, Ricardo M. Fernandes, Johan Vande Walle, and Saskia N. de Wildt. “Development and Performance of the C4c National Clinical Trial Networks for Optimizing Pediatric Trial Facilitation.” Frontiers in Pediatrics 11 (2023): 1302272. https://doi.org/10.3389/fped.2023.1302272. Attar, Sabah, Angie Price, Collin Hovinga, Breanne Stewart, Thierry Lacaze-Masmonteil, Fedele Bonifazi, Mark A. Turner, and Ricardo M. Fernandes. “Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery.” Therapeutic Innovation & Regulatory Science 58, no. 5 (September 2024): 953–64. https://doi.org/10.1007/s43441-024-00663-0. Degraeuwe, Eva, Collin Hovinga, Annelies De Maré, Ricardo M. Fernandes, Callie Heaton, Lieve Nuytinck, Laura Persijn, Ann Raes, Johan Vande Walle, and Mark A. Turner. “Partnership of I-ACT for Children (US) and European Pediatric Clinical Trial Networks to Facilitate Pediatric Clinical Trials.” Frontiers in Pediatrics 12 (2024): 1388170. https://doi.org/10.3389/fped.2024.1388170.
Number of competitive grants obtained in the last 5 years 1 Network lead academic input and network level input, including organisational, processes, activities and portfolio data
Access to expert groups Yes The Portuguese Society of Pediatrics with its specialty groups is a Third Party to STAND4Kids in the c4c project
Capacity to answer external scientific questions Yes STAND4Kids can: support feasibility requests at national and site level; oversee and support site setup/readiness and performance; support the implementation of standards and training activities for the qualification and capacity building of national sites; link with national experts on design, conduct and analysis of pediatric clinical trials/studies. The single national contact point should be used stand4kids@medicina.ulisboa.pt. These activities align with c4c processes whenever applicable.
Site feasibility Yes Not publicly accessible. Aligned with c4c processes whenever requested/applicable
Participant recruitment Yes Not publicly accessible. Aligned with c4c processes whenever requested/applicable
Budget calculation for studies Yes Not publicly accessible. Aligned with c4c processes whenever requested/applicable