3 - Specific competencies and capacity to provide export advice
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
FINPEDMED - Finnish Investigators Network for Pediatric Medicines |
|
| Number of peer reviewed publications in the last 5 years | 7 | 1. Informed Consent and Assent Guide for Paediatric Clinical Trials in Europe. Lepola P., Kindred M., Giannuzzi V., Glosli H., Dehlinger-Kremer M., Dalrymple H., Neubauer D., Boylan G., Conway J., Dewhurst J., Hoffman D. Arch Dis Child. December 01, 2021. doi: 10.1136/archdischild-2021-322798 2. Lepola P, Wang S, Tötterman AM, et al. Does the EU’s Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross- sectional study. BMJ Paediatrics Open 2020;0:e000880. doi:10.1136/bmjpo-2020000880. Accepted 1 December 2020. 3. Severin, T., Corriol-Rohou, S., Bucci-Rechtweg, C. et al. Correction to: How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement. Ther Innov Regul Sci, 2020. https://doi.org/10.1007/s43441-020-00152-0 4. Tardy development of safe medicines for children; A Nordic network offers new platform to reduce this inequity. Naumburg E., Rane A., Halvorsen T., Glosli H., Henriksen T. B., Haraldsson À., Kallio J., Lepola P. Acta Paediatrica, 07March2019. doi: 10.1111/apa.14775. 5. Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey. Gareth J Veal, Salma Malik, Mariangela Lupo, Susan MacFarlane, Pirkko Lepola, Mary Costello, Adriana Ceci, Carine Boué, Charlotte Lecour, Annette Otto, Maryam Rastegari, Philip Berry. BMJ Paediatrics Open Sep 2017, 1 (1) e000170. 6. Pharmaceutical Industry and Paediatric Clinical Trial Networks in Europe – how they communicate? Pirkko Lepola, Susan Tansey, Pamela Dicks, Jennifer Preston, Martine Dehlinger-Kremer. Applied Clinical Trials, Jan 08, 2016. Appliedclinicaltrialsonline.com 7. Informed consent for paediatric clinical trials in Europe. Lepola P, Needham A, Mendum J, Sallabank P, Neubauer D, de Wildt S. Arch Dis Child. 2016 May 25. |
| Number of competitive grants obtained in the last 5 years | 2 | Executive secretary of FINPEDMED has been one of the authors. |
| Access to expert groups | Yes | Experts as members in different specialities in the network. |
| Capacity to answer external scientific questions | Yes | Experts in different specialities in the network. Standardized operational process to receive and distribute service requests via single contact point (FINPEDMED office), and negotiate Consultation Agreements with the companies. |
| Site feasibility | Yes | The Service Request model procedure. Standardised procedure for linking sponsor with investigator/site for feasibility assessment and the expert Consultations. |
| Participant recruitment | No | |
| Budget calculation for studies | No |