European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management



    Description

Name

 

EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative)

Documented adherence to GCP guideline Yes All documents related to adherence to clinical trial legislation and Good Clinical Practice (GCP) guideline are available from the EPTRI Members.
Documented adherence to the ethical considerations for clinical trials in children Yes All documents related to the adherence to the ethical considerations for clinical trials are available from the EPTRI Members.
Documented adherence to ethical considerations Yes EPTRI provides the paediatric community with advice on Paediatric Medicine Development Issues; advice on relevant Ethical, Legal and Societal Issues (ELSI) in a children/fundamental rights perspective (e.g. data protection, right to health protection…); advice on children empowerment and engagement in paediatric studies; easy dissemination of relevant information; documents and recommendations in the field of paediatric study methodology and ELSI.
Availability of Standard Operating Procedures (SOP) Yes SOPs are available from the EPTRI Members.
Capacity to monitor studies
(academic trials industry sponsored trials)
Yes Monitoring and related SOPs are available from the EPTRI Members.
Capacity to monitor performance of collaborating centres Yes Procedures and SOPs are available from the EPTRI Members.
Quality control and quality assurance, raceability and data safety Yes Quality Assurance Processes and SOPs are available from the EPTRI Members.