Vaccinology and Pharmaceutical Clinical Development (Executive)

Course Structure

1. Module I: Public Health and Vaccine Development Process;
2. Module II: Vaccine Immunology and Preclinical Research;
3. Module III: Vaccine Manufacturing and Quality Control Processes;
4. Module IV: Infectious Diseases and Vaccine Prevention;
5. Module V: Clinical Development Methodology, Biostatistics and Clinical Data management;
6. Module VI: Pharmacovigilance;
7. Module VII: Epidemiology, Health Systems and Economics;
8. Module VIII: Good Clinical Practices, Clinical Quality Assurance and Clinical Trial Operations;
9. Module IX: Regulatory Affairs;
10. Module X: Policies and Recommendations for Vaccines in the World;
11. Extra Curriculum: parallel educational seminars for personal and professional development.
12. 1 month at the University of Siena within its different departments at the university hospital and public health centers;
13. 6 months within different departments of the sponsors and collaborative institutions, followed by investigational site training.
14. Each student selects a subject for a written thesis;
15. The thesis will be submitted to the University of Siena Medical School and evaluated by a panel of experts (written and oral presentation) during the public thesis defense at the end of the 18 months program.
16. First step: students have to pass 10 modules written exams achieving the official minimum grade to proceed to the thesis defense;
17. Second step: students have to achieve the minimum thesis grade.