Benefit risk assessment for oncology treatment in various contexts :  
Marketing autorisation applications  – Centralised procedures  
Assessment of clinical data on safety and efficacy for the general population 
Derogatory authorisations : 
– Early access authorisations (previously Cohort temporary use authorisations) : Assessment of a strong presumption of positive benefit risk ratio in a specific population 
– Commpasionate use authorisations : individual benefit risk assessment for patients in total absence of therapeutic alternatives 
Clinical trials applications : 
Assessment of the approriatness of securisation measures applied in the clinical trial protocol with regard to the available information on the safety profile of the experimental product, the relevance of the clinical trial rationale and the absence of loss of chances for the patients to be included in the study versus the standard of care