European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

PCIC - Pediatric Clinical Investigation Center, Belgium

Existence of an identified contact person for external enquiries Yes
Existence of an internal steering committee Yes
Existence of an external advisory steering committee directing the reporting party No
Existence of a website Yes
Existence of newsletter Yes
Existence of internal databases for disease, condition treatment and/or outcome Yes we use in-house databases within the different paediatric sub-specialities
Provisions to ascertain data protection and data security Yes Described in our quality syste, compliant with ICH-GCP, AAHRPP accreditation and (inter)national lesgislation and guidelines
Procedures to access the database by third parties Yes described in our quality system
Access to external databases/registries No
Standardised process to access an external database No