People everywhere need life-saving vaccines and medicines. But those in developing countries need them even more – and they need them now.
But making this happen is not simple. It requires trained professionals to rollout effective national immunization plans, to generate local clinical data on vaccine safety and efficacy, to measure impact of immunization programs, and to share their public health expertise with others.
This means equipping local healthcare professionals with skills and competencies that are of the highest standards.
Through our Master Program in Vaccinology and Drug Development, every year we select and train the best and most passionate bachelors from developing countries, giving the scientific and practical know-how they need to lead the new generation of public health professionals, when back home. Our aim is on candidates from countries that are most in need of sustainable immunization programs and timely access to quality, cost-effective vaccines and medicines.
Graduates of our program return home with a better understanding of their countries’ epidemiology and public health needs, and a broad knowledge about vaccinology and immunization. Being trained theoretically and practically by the world’s most reknowned experts in vaccinolgy and immunization, they bring back confidence and hope where it is needed most.
The Master Program of the University of Siena offers a hope for development.
% OF THE STUDENTS ARE IN THE FIELD OF VACCINOLOGY & DRUG DEVELOPMENT
We want our graduates to be leaders in academia, public health, and R&D focused on vaccines and medicines. That’s why we offer an internationally recognized program delivered by top-class experts from international universities, supranational organizations and industry.
The curriculum is conducted in English and features a 1-year course lenght divided into theorical classes and practical internship at academia, industry, NGO, CROs, amongst others.
As clinical development, public health and regulatory regulations frequently change, our Scientific Board, makes sure that these are constantly updaded in the program, ensuring updated and quality information.
The program culminates with the submission of a thesis and the awarding of a Master’s Diploma from one of the oldest and most respected European universities, the University of Siena.
What do the students learn?
There are 10 modules, each designed to prepare our students to play an active role in the complex system of preventive and therapeutic medicine in the world. From these modules, they would acquire the necessary knowledge and tools to assess and improve immunization programs, to lead clinical trials, and to understand regulatory and pharmacovigilance environments in the developing world.
Developing vaccines and medicines is a lengthy, costly, and complex regulated process that demands specific expertise in the area of vaccinology and in pharmaceutical development. This process does not end at product registration, it goes beyond it.
Experts are needed at central and local levels of national and supranational authorities and global communities to ensure an adequate financing mechanism, product introduction, and surveillance of impact. Local experts are needed to ensure proper planning for a sustainable immunization program. The national surveillances must monitor the outcome and impact via the epidemiologic results, control of diseases, vaccine safety, and public health impact.
Each student progress is assessed through written exams, reports, individual and group assignments, internships evaluation and professors’ feedback. At the end of the program, the final step in evaluation comes from a written thesis and its defense.
Theoretical program – Modules*
VACCINE IMMUNOLOGY AND PRE-CLINICAL RESEARCH
Basic concepts of immunology, immune response to vaccines, and how to translate this into vaccine development and licensing.
PUBLIC HEALTH, VACCINE DEVELOPMENT PROCESS AND POLICY MAKING
A general overview on immunization and public health in the world. Deepens students’ understanding of the overall principles of pharmaceutical development process, with the ultimate objective of ensuring sustainability of life saving vaccination programs at the global level.
Principles of clinical trial methodology, especially focused on the vaccine development pathway, from the Target Product Profile to the Clinical Development Plan, basic concepts of statistics and data management for clinical trials.
VACCINES PREVENTABLE DISEASES
To understand the pathogenesis, clinical evolution, immune response, epidemiology, morbidity and mortality of vaccine preventable diseases to have the tools to critically analyse the pathways for vaccine development and deployment, as well as implementing public health measures.
To understand basic principles of Epidemiology applied to vaccines, and Health Economics and contribute to generate information to support vaccine development.
To understand the requirements and to ensure quality in clinical trials execution and the operational requirements for planning and executing vaccines clinical trials (ethical considerations, site feasibility, recruitment aspects, monitoring and quality assurance).
To understand main rational, best practice and present overview on Pharmacovigilance systems in the world. The learning is focused on: how to write an individual case narrative, how to assess causality and expectedness of cases, how to determine certainty of diagnosis according to Brighton collaboration guidelines.
PHARMACEUTICAL DRUG DEVELOPMENT
To understand the drug development process, from bench to market and product lifecycle. Besides the understanding from end-to-end Drug R&D, the student will have practical activities on Phase I to IV case studies and regulatory mock-up submissions.
MANUFACTURING AND QUALITY PROCESS CONTROL
The aim is to get an understanding of concepts, methods and challenges of technical operations and quality of vaccine manufacturing.
To understand the international regulatory environment and requirements related to obtaining approval for vaccines and the maintenance of these licenses.
*Modules order can change on the effective program calendar
Students have the oppourtunity to develop invaluable hands-on experience while spending 4 to 6-months at different departments of our educational Partners and Sponsors, such as, WHO, CEPI, IVI, Clinton Health Access Initiative; Universities of Oxford, Surrey, Texas, Sao Paulo, Siena, Imperior College London; Cameroon Ministry of Health; Sanofi Pasteur, Novartis, Takeda, CureVac, VaxTrials, Intrials, CeVaxin, Syneos Health, GSK, CSL Behring.
Students have an opportunity to contribute to the daily work at the departments and can benefit from the guidance of an expert mentor who works closely with them during the internship.
We are building capacity for sustainable end-to-end vaccine R&D, enhancing technical and scientific skills, focusing on LMIC. This is how the Master Program in Vaccinology and Drug Development is making a difference for over a decade of dedication.
Our alumni have taken up a range of key roles in their own countries; applying expertise learned at the University of Siena where it is needed most. They run vaccine clinical development and pharmacovigilance programs; work as research scientists; teach in academia; help to raise the standards of vaccine manufacturing in the developing world; and work in their communities as GPs and public health advocates.
The Master’s coordination team actively follows former students for minimum of five years post-graduation. Over 99% of alumni are actively working in vaccinology or public health five years after completing the program.
Imagine how much more we can do.
OF GRADUATES ACTIVE IN
(Some of our EDUCATIONAL PARTNER INSTITUTIONS)
WHO, CEPI, EMA, PEI, IVI, CDC, BMGF, ECDC, PATH, GAVI, FIOCRUZ, CHERMID, CHMO, ANVISA, CHAI; European Community, Sabin Institute, Health Dep. London, Health Dep. Italy, Tropical Lab Antwerp, Federal Agency Belgium, Institute Pasteur, MRC Gambia, Welcome Trust, Cameroon Ministry of Health; VisMederi, Brighton Collaboration, Novartis, Sanofi Pasteur, Roche, G-Con, Biological E. Limited, Clover BioPharma, GSK Mexico, Pfizer, Medicago, Valneva, Curevac, GRID EUROPE, IBET, Intrials, Syneos Health, VaxTrials, CeVaxin, Lemann; University of Cincinnati Children’s Hospital, University of Tubingen, University of Brussels, University of Mainz, University of Halifax, University of Namur, Karolinska Institutet, University of Yale, Oxford University, London School of Hygiene and Tropical Medicine, Imperial College of London, University of Sao Paulo, Boston University, CPE-Lyon engineer school