Regulatory Affairs

The courses in this module will give you an overview on medicines regulation including the different marketing authorisation procedures, benefit-risk assessment, pharmacovigilance, pharmacoepidemiology and other relevant aspects, and the role which patients can take in these processes.

Important note: term ‘regulations’ can be used in different contexts while an EU regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. EU regulations can be distinguished from EU directives which, at least in principle, need to be transposed into national law.