Public Health and Vaccine Development Process

A general overview on immunization and public health in the world. Deepens students' understanding of the overall principles of pharmaceutical development process.

Module's directors

Emanuele Montomoli, BSc, MSc, Full Prof.

President of the Master TSC, Full Prof. of Public Health
Dept. of Molecular and Developmental Medicine, University of Siena, Italy

Sue Ann Costa Clemens, MD, PhD, Professor

Prof. of Pediatric Infectious Diseases Director Master Program in Vaccinology Head of Institute for Global Health
Dept. of Molecular and Developmental Medicine, University of Siena

Contents

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Lessons' List

Introduction to Module 1
Vaccines Academy introduction: educational programs (Master, PhD and Post-Doctoral)
University of Siena - Master Program
The factors of success of the immunization program in Brazil
Private and public health care systems in Brazil
Latin American Immunization Schedule
Clinical trials in developing countries: Asia / Africa
EPI studies
Vaccines investments in developing world
Clinical trials and other public health activities
Life in health care (Q & A session with expert)
Fiocruz: a government producer overview
Vaccine development from research to launch… and beyond
The global vaccine market (global and local vaccine companies; private public partnerships)
Differences between vaccines & pharmaceuticals development
Private and public partnerships : country perspective and benefits for a country
The value of vaccines
Asian vaccine markets (public, private)
Public and private health care systems
Medical Affairs and commercial overview
The Italian immunization system
Industry environment and its different aspects: business development / Intellectual Property
Sabin Institute : overview and projects
A successful EPI and its implementation
30 years of experience of immunization
Eradication of polio, measles, rubella, and CRS in the Americas
Global Vaccination Policy Setting and examples from Latin America
Infrastructure, sustainability - developing countries /PAHO
Key aspects on setting immunization priorities: country / regional perspective
PV how to implement surveillance
How to sustain the introduction of vaccines
Key barriers to achieve a good coverage
Eradication of diseases after smallpox, part 1
Eradication strategies Part 2
Case Study
What is portfolio management & project management overview
Vaccine development plan management - case study
Risk management - case study in clinical trial
Project communication / reporting progress
Vaccine research and development for and in Africa
Vaccine licensure process in Europe and US
Work out session: students to prepare a presentation on clinical trial submission, data requirement and regulatory harmonization in their Regions
Building sustainable power networks for clinical development
Clinical development from different perspectives (industry, NGO, academic perspectives)
Vaccines Academy: PhD program

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