Master in Regulation and Evaluation of Medicines and Health Products

7

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

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