For clinical trials and drug authorisation, the CESP is a simple and secure portal provided by the HMA to exchange information between applicants and European Medicines Regulatory Agencies (link below).
The purpose of the system is to:
• Provide a secure method of communicating with the Regulatory Agencies via one platform
• Allow submission of an application once to reach all required Agencies
• Reduce the burden for both companies and Regulators of submitting/handling applications on CD-ROM and DVD
• This portal can be used for submitting Clinical trials, Development Safety Update Reports (DSURs), Marketing Authorisation submissions,...
This portal is used by European Regulatory Authorities (e.g. Belgium) but so far Luxembourg Authorities (Ministry of Health) do not use this portal and still require hard copies.
LIH has been registered into the portal. The company administrator for LIH is Dr Nancy De Bremaeker, Clinical Research Coordinator at the Clinical and Epidemiological Investigation Centre (CIEC) at the Department of Population Health.
Should you have questions or submissions to regulatory authorities please contact Nancy: firstname.lastname@example.org / Phone +352 26 970 804
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.