European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process

    Description

Name

  

EUNETHYDIS - European Network for Hyperkinetic Disorders
Existence of an identified contact person for external enquiries Yes Prof. Dr J.A.Sergeant
Existence of an internal steering committee Yes Internal steering committee: Prof. J. Sergeant, Dr. D. Coghill, Prof. T. Banaschewski, Prof. E. Sonuga-Barke, Prof. M. Holtmann, Dr. S. Cortese, Prof Chris Hollis, Prof Emily Simonoff
Existence of an external advisory steering committee directing the reporting party No
Existence of a website No Under Construction
Existence of newsletter No All network communications are published in scientific journals.
Existence of internal databases for disease, condition treatment and/or outcome No Due to privacy issues internal data bases/disease registries are located at each of the participating clinics. There are also cross site databases of of genetic data that have arisen as a consequence of specific projects. Through Prof. I. Wong the network has access to a range of pharmacoepidemiological databases and through extrenal collaborations we are able to access to several other large long term prospective databases as required for specific projects.
Provisions to ascertain data protection and data security Yes All databases comply with national and international standards for data protection.
Procedures to access the database by third parties Yes All database comply with national and international standards for allowing access to third parties as appropriate.
Access to external databases/registries Yes As noted in 2.6, members of the network have, through their research collaborations, privileged access to a broad range of large research databases not usually accessible to the public. In addition, the network has access to several large national and international pharmacoepidemiological and pharmacovigilence databases. The Network is in discussion with the EMA to be a pilot site for accessing their pharmacovigilence database. In addition we have a long history of collaborative work with industry partners which includes participation in data mining panels and assisting with the design and implementation of data mining projects of large clinical trials datasets.
Standardised process to access an external database Yes Due to the wide range of databases used in various projects and the very different requirements set out by the owners of these data these are negotiated and defined as required.