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Regulatory Affairs

The courses in this module will give you an overview on medicines regulation including the different marketing authorisation procedures, benefit-risk assessment, pharmavigilance, pharmacoepidemology 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.


Introduction to Regulatory Affairs


After completing the course, you will be able to:

10 hours
EUR 8.00

Epidemiology and Pharmacoepidemiology


After completing the course, you will be able to:

  • Illustrate the basic concepts of ...

8 hours
EUR 8.00

Pharmacovigilance - Risk management


After completing the course, you will be able to:

8 hours
EUR 8.00

Product information and information to the public

After completing the course, you will be able to:
  • Describe the components of product information ...

8 hours
EUR 8.00

Regulatory procedures- Marketing-Authorisations and their lifecycle management

After completing the course, you will be able to:
8 hours
EUR 8.00