European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

PENTA- ID - Paediatric European Network for the Treatment of AIDS and Infectious Diseases

Existence of an identified contact person for external enquiries Yes via website
Existence of an internal steering committee Yes PENTA-ID Steering Committee fully established
Existence of an external advisory steering committee directing the reporting party Yes
Existence of a website Yes www.penta-id.org
Existence of newsletter Yes PENTA-ID news updated through he website
Existence of internal databases for disease, condition treatment and/or outcome Yes National and city-wide cohort databases held by partners such as the CHIPS database (1000 HIV infected children prospectively followed) (www.chipscohort.ac.uk) are held by the MRC for the UK and Ireland. These cohort can help identify clinical sites with eligible patients and inform sample size calculation and drug utilisation. New cohort study focussing on antimicrobial use in Europe - Antimicrobial Resistance and Prescribing in European Children - www.arpecproject.eu )
Provisions to ascertain data protection and data security Yes All data are held on secure MRC or INSERM databases and handling of paper data conforms to European and national data protection standards
Procedures to access the database by third parties Yes External investiagtors contact the PENTA SC for any potential data requests related to planned studies. This includes pharma requests or investigator led requests.
Access to external databases/registries Yes PENTA-ID has privileged access to country specific national paediatric HIV data bases. PENTA works to facilitate datasharing across Europe
Standardised process to access an external database Yes