European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process

    Description

Name

  

FINPEDMED - Finnish Investigators Network for Pediatric Medicines
Existence of an identified contact person for external enquiries Yes see identification
Existence of an internal steering committee Yes Steering Committee includes 1 representative of each University Hospital (5) and Chair. Members are appointed by the pediatric clinics. https://finpedmed.fi/en/info/organisation/
Existence of an external advisory steering committee directing the reporting party No
Existence of a website Yes www.finpedmed.fi and www.finpedmed.com and www.nordicpedmed.com
Existence of newsletter Yes Monthly up-date info via e-mail to members.
Existence of internal databases for disease, condition treatment and/or outcome Yes FINPEDMED/NordicPedMed has an internal Investigators Registry, which is closed and used only internally (i.e. all data is secured). Additionally, all trial requests, incl. sponsor information and detailed trial related information and documentation, is saved and compiled as statistics, which constitutes a FINPEDMED own statistical database. This database does NOT include any patient level data or treatments or outcomes.
Provisions to ascertain data protection and data security Yes Patient data proctected in hospitals' and clinics' patient records - not within the network (office). All personal data are treated in compliance with the Regulation (EU) 2016/679 of the European Parliament and of the Council, and according to the national level Personal Data and Health Data protection laws.
Procedures to access the database by third parties No
Access to external databases/registries Yes https://findata.fi/en/ .Standardized processes in place at national level for access to relevant external national databases for research (Not only for the network members).
Standardised process to access an external database Yes https://findata.fi/en/