Master in Regulation and Evaluation of Medicines and Health Products

Quality of Medicines I



Learning outcomes

At the end of the course students should demonstrate integrated knowledge of the scientific principles that support the quality of medicines, particularly the critical quality attributes of the active substance and the drug product. The CTD (Module 3) will be used as a guide to the different quality issues, which will be developed in each teaching module. The focus is not only to develop specific aspects of each critical quality attribute, but also to establish clearly their common scientific base within a multidisciplinary field, such as quality assessment.
In addition to the basic and general concepts needed, the students should master the international regulatory framework ruling quality assessment, mainly those issued by the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and the International Conference on Harmonisation (ICH).


Study of the most relevant quality issues pertaining to the active substance and drug product, according to the Common Technical Document (CTD; Module 3):

  • Regulatory and GMP issues of active
  • Control and stability of drug
  • Quality issues of water for pharmaceutical
  • Development
  • In-process controls, control of intermediate products and control of drug
  • Manufacturing process
  • Validation of sterile
  • Packaging process
  • Stability of drug
  • Regulatory issues of modified-release dosage forms and new drug delivery
  • Regulatory issues of nanomedicines: quality vs
  • Regulatory issues of biotechnology