Master in Regulation and Evaluation of Medicines and Health Products

Clinical Trials

ECTS

7

Learning outcomes

General goals:

  1. Lexis acquisition related to clinical trials
  2. Knowledge about ethical principles on clinical trials
  3. Knowledge about clinical trials history
  4. Knowledge about clinical trials organization
  5. Knowledge about legal from on clinical trials
  6. Development skills on clinical trials analysis
  7. Knowledge about the importance of clinical trials on medicines approval

Syllabus

  1. Clinical trials history
  2. Clinical trials classification
  3. Ethical issues on clinical trials
  4. Patient recruitment
  5. Informed consent
  6. Clinial trials randomisation
  7. Clinical trials validation
  8. How to evaluate efficacy and safety on clinical trials
  9. ConSORT
  10. ICH 10 discussion
  11. ICH 8 discussion
  12. Clinical trials legal framework

Share