• Assessment of dossiers to be submitted to EMEA (European Agency for the Evaluation of Medicines), COMP (Committee for Orphan Medicinal Products), National Authorities to foster compliance with the regulatory procedures ensuing from European Union legislation • Design and management of clinical trials implementing GCP (Good Clinical Practice) and other provisions and guidelines for conducting clinical trials in human population, including special populations (paediatrics and rare disease patients). • Pharmacoepidemiological survey and drug utilisation studies. • Economic assessment – cost/effectiveness, cost/benefit and cost/utility analyses - on health care technologies (drugs, diagnostics, programs, organizational models). • Cost analysis of new therapies and their application. • Development and evaluation of tools for quality-of-life assessment. • Design and management of training courses (CME) targeted to health professions, public health administrators and pharmaceutical organisations