Ensuring a centralised, effective and transparent service that guarantees the handling of national STA applications within the statutory timeframe.
Validation, management, comprehensive coordination and closing of applications for national STA.
Handling general as well as specific file related questions about national STA services.
Consistent follow-up of previously granted national and European advice via channels including the Belgian representatives of SAWP and SAWP-V, CAT, CHMP and PDCO of EMA.
Administrative management of European advice requests coordinated by Belgian SAWP members.
Management of the STA-SAWP database of FAMHP.
Coordination of portfolio meeting requests, which are high-level informative meetings between the parties requesting advice and experts, scientific coordinators, spearhead coordinators, persons in charge at FAMHP and FAMHP representatives at European level.
Coordination of project infomeeting requests, which are informal meetings between the applicant and the FAMHP experts to discuss scientific research projects concerning innovative medicines at an early stage.
Management of the internal and external expertise network at national and European level including the management of the expert database and the KM project.
Improvements to and expansion of new strategic partnerships and interaction mechanisms with external experts in line with the further expansion, consolidation and distribution of external expertise.
Coordination of and participation in various projects within FAMHP that are important for building up expertise and the further expansion of national STA services. This concerns projects such as the renewed CGH-CMH, expertise on medical devices and knowledge management.
Active participation in the working group for developing the EARLY PHASE DEVELOPMENT and VACCINES spearhead.