1. health and fitness
2. disease
3. cold and flu

Organization:
Novartis Vaccines Academy (Master Coordination)
Venue:
University of Siena Medical School, Siena - Italy (Hospital and Laboratories)
Novartis Vaccines and Diagnostics S.r.l., Siena - Italy (Development Departments, Research
Center and Laboratories)
Novartis Vaccines Institute for Global Health S.r.l., Siena - Italy
Sanofi Pasteur S.A., Lyon - France
University of Oxford – Oxford Vaccine Group, Oxford - UK
University of Surrey, Guildford - UK
Public Health (Immunization Centers), Siena - Italy
Duration:
May 2015 – November 2016
Sponsors
Letter from the Director
Sue Ann Costa Clemens, MD,PhD
Prof. Pediatric Infectious Diseases
Director Novartis Vaccines Academy
To this date much of the developing world poses many challenges to enjoying life free of vaccine
preventable diseases; despite most government’s good-will and the desire to ease the burden of these
diseases. To achieve this goal, developing countries need to have native, well-rounded professionals in
the fields of immunization, public health and infectious diseases. Professionals who can appreciate the
impact of vaccine preventable diseases from different angles: value of vaccines, vaccine research and
development, vaccine safety, vaccine procurement and vaccine delivery. Likewise, health care
professionals from developed countries would benefit for themselves and would contribute to global
health by more in-depth understanding of the contribution of immunization and vaccines to global
development.
The Master Program in Vaccinology and Pharmaceutical Development provides high quality education
involving world-wide key opinion leaders. This program which started in 2008, has graduated more
than 30 students from the developing world who are now making a difference in their countries. This
year, 15 new Vaccinology professionals from Africa, Asia and Latin America will go back to their
countries to start new careers. I am confident that very soon we will see the impact that they will have
through their contributions.
This program demands excellence in every aspect, from the worldwide expertise of the teaching staff
to the student’s level of commitment and dedication. I am particularly impressed with their true desire
to learn, improve and make a difference in their countries.
The success of this program is a collaborative effort and a unique partnership between industry and
academia to help developing countries to overcome some of the gaps in vaccinology, via a very solid
tool - Education. This program helps the countries to build their own resources, to disseminate
knowledge, to develop new professionals and specially helps the developing countries to be
independent on key aspects as pharmacovigilance, regulatory and epidemiology.
Sincerely,
Prof. Dr. Sue Ann Costa Clemens
The Technical Scientific Committee
Prof. Emanuele
Montomoli
Director TSC
Head Department of
Molecular and
Developmental, University
of Siena
Prof. Sue Ann Costa
Clemens
Director Novartis Vaccines
Academy
Prof. In Pediatrics
Infectious Diseases
Prof. Ranuccio Nuti
Department of Internal
Medicine, University of
Siena
Dr. Stefania Rossi
Researcher of Public
Health
Dept. of Molecular and
Developmental Medicine
Area of Public Health,
University of Siena
Prof. Franco Laghi
Pasini
Head Department of
Clinical Medicine and
Immunology, University of
Siena
Dr. Audino Podda
Head Clinical
Development and
Regulatory Affairs, Novartis
Vaccines Institute for
Global Health
Dr. Giovanni Della
Cioppa
Head Clinical
Development Clusters,
Novartis Vaccines
Dr. Emanuela Palla
Head Early Projects GPT
Head Italy RSO,
Novartis Vaccines
Content
The Master Course ............................................................................................................................................................... 1
Goals ................................................................................................................................................................................. 1
Concept............................................................................................................................................................................ 1
Program overview ........................................................................................................................................................ 2
Program agenda (One year) .......................................................................................................................... 2
Internship (Six months) ................................................................................................................................... 2
Students Evaluation .................................................................................................................................................... 2
Thesis ...................................................................................................................................................................... 2
Module I .................................................................................................................................................................................... 4
Public Health and Vaccine Development Process ......................................................................................... 4
Module Directors ................................................................................................................................................ 4
Aim ........................................................................................................................................................................... 4
Contents ................................................................................................................................................................. 4
Module II ................................................................................................................................................................................... 5
Vaccine Immunology and Pre-Clinical Research ........................................................................................... 5
Module Directors ................................................................................................................................................ 5
Aim ........................................................................................................................................................................... 5
Contents ................................................................................................................................................................. 5
Module III ................................................................................................................................................................................. 6
Vaccine Manufacturing and Quality Control Processes............................................................................... 6
Module Directors ................................................................................................................................................ 6
Aim ........................................................................................................................................................................... 6
Contents ................................................................................................................................................................. 6
Module IV ................................................................................................................................................................................. 7
Infectious Diseases and Vaccine Prevention .................................................................................................... 7
Module Directors ................................................................................................................................................ 7
Aim ........................................................................................................................................................................... 7
Contents ................................................................................................................................................................. 7
Module V .................................................................................................................................................................................. 9
Clinical Development Methodology, Biostatistics and Data Management .......................................... 9
Module Directors ................................................................................................................................................ 9
Aim ........................................................................................................................................................................... 9
Contents ................................................................................................................................................................. 9
Module VI .............................................................................................................................................................................. 12
Pharmacovigilance ................................................................................................................................................... 12
Module Directors ............................................................................................................................................. 12
Aim ........................................................................................................................................................................ 12
Contents .............................................................................................................................................................. 12
Module VII ............................................................................................................................................................................. 13
Epidemiology, Health Systems and Health Economics ............................................................................ 13
Module Directors ............................................................................................................................................. 13
Aim ........................................................................................................................................................................ 13
Contents .............................................................................................................................................................. 13
Module VIII ............................................................................................................................................................................ 14
Good Clinical Practice, Clinical Quality Assurance and Clinical Trial Operations .......................... 14
Module Directors ............................................................................................................................................. 14
Aim ........................................................................................................................................................................ 14
Contents .............................................................................................................................................................. 14
Module IX .............................................................................................................................................................................. 16
Regulatory Affairs ..................................................................................................................................................... 16
Module Directors ............................................................................................................................................. 16
Aim ........................................................................................................................................................................ 16
Contents .............................................................................................................................................................. 16
Module X ............................................................................................................................................................................... 17
Policies and recommendations for vaccines in the world ....................................................................... 17
Module Directors ............................................................................................................................................. 17
Aim ........................................................................................................................................................................ 17
Contents .............................................................................................................................................................. 17
Special Topics ..................................................................................................................................................................... 19
Aim ........................................................................................................................................................................ 19
First and second semester .......................................................................................................................... 19
How to proceed .................................................................................................................................................................. 20
Entry Requirements ................................................................................................................................................. 20
Funding ......................................................................................................................................................................... 20
Application & Information ..................................................................................................................................... 20
Application to the University of Siena .................................................................................................... 20
Contact information .......................................................................................................................................................... 21
Introduction
The Master Course
Goals
•
•
Capacity building in vaccinology and vaccine development;
To prepare students for a career in academia, public health and research and
development in public and private vaccine institutes.
Concept
•
To provide graduates in medicine with training in epidemiology and disease burden of
vaccine preventable infectious diseases, vaccine development from research to licensure
and vaccine policy and funding;
•
•
Is a collaborative effort between academia and vaccine industry;
Combines theoretical and practical training in immunology, infectious diseases and
vaccinology, from research to licensure. The training is given by worldwide experts from
academia, well known international universities, supranational organizations (e.g. EMA,
Sabin Institute, Bill & Melinda Gates Foundation) and industry.
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The Program
Program overview
Program agenda (One year)
•
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Module I: Public Health and Vaccine Development Process;
•
•
•
Module VI: Pharmacovigilance;
•
•
•
Module IX: Regulatory Affairs;
Module II: Vaccine Immunology and Preclinical Research;
Module III: Vaccine Manufacturing and Quality Control Processes;
Module IV: Infectious Diseases and Vaccine Prevention;
Module V: Clinical Development Methodology, Biostatistics and Clinical Data
management;
Module VII: Epidemiology, Health Systems and Economics;
Module VIII: Good Clinical Practices, Clinical Quality Assurance and Clinical Trial
Operations;
Module X: Policies and Recommendations for Vaccines in the World;
Extra Curriculum Modules: Special Topics.
Internship (Six months)
•
six-month internship:
o within different departments of the Novartis Vaccines, Sanofi-Pasteur,
Universities of Surrey and Oxford;
o at the University Hospital of Siena;
•
clinical site visits:
o investigators meeting / site feasibility
o study start/closure
o monitoring
Students Evaluation
•
•
Written exams after each module and a cumulative one at the end of the first year;
Internship: students’ performance is assessed by supervisors and master coordination
based on activities and overall training and deliverables during the 6 month internship
period.
Thesis
•
•
Each student will select a subject for a written thesis;
The thesis will be submitted to University of Siena and discussed at the end of the
Program.
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Modular Program
Module I
Public Health and Vaccine Development Process
Module Directors
•
•
Prof. Emanuele Montomoli - Professor of Public Health, University of Siena, Italy
Prof. Sue Ann Costa Clemens - Prof. Pediatric Infectious Diseases, Director Novartis
Vaccines Academy
Aim
To get a general overview on immunization and public health in the world and to understand the
overall principles of pharmaceutical development process from research to the market.
Contents
•
•
•
•
•
•
•
•
•
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Public Health basic concepts;
The role of vaccines in public health;
Role of stakeholders;
Governments, NGO’s, Supranational Organizations;
Academia;
Vaccine industry;
Vaccine development process;
From research to licensure and recommendations;
How vaccine companies function;
How to manage projects in vaccine companies;
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Module II
Vaccine Immunology and Pre-Clinical Research
Module Directors
•
Prof. Emanuele Montomoli - Head Department of Molecular and Developmental,
University of Siena, Italy
•
•
Dr. Giuseppe Del Giudice - Global Head Translational Medicine, Novartis Vaccines
Dr. Emanuela Palla - Head Early Projects GPT, Head Italy RSO, Novartis Vaccines
Aim
To understand the basic concepts of immunology, immune response to vaccines and how to
translate this into vaccine development and licensing.
Contents
•
Historical background to vaccination:
o Human Immune response:
Innate immunity;
B-cell and T-cell responses;
How to measure B and T cell function.
•
Identification of vaccine targets:
o Antigen structures as potential vaccine candidates;
o Conventional and novel approaches to vaccine development.
•
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Type of vaccines;
The role of adjuvants;
Pre-clinical evaluation of vaccine immunology and safety;
Analysis of immune response to vaccines in humans:
o Antibody response;
o Functional assays versus quantitative assays.
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Module III
Vaccine Manufacturing and Quality Control Processes
Module Directors
•
•
Prof. Emanuele Montomoli - Professor of Public Health, University of Siena, Italy
Dr. Massimo Bugnoli - Technical Operations, Novartis Vaccines
Aim
To get an understanding of concepts, methods and challenges of technical operations and quality
of vaccine manufacturing.
Contents
•
•
History of vaccine production, challenges and advances;
•
Organization:
o Procedures and flows in manufacturing and control vaccines;
o Plant structure and layout, shifts.
•
Importance of Good Manufacturing Practices (GMP) to guarantee an immunogenic and
safe product:
o Selection of raw materials;
o Systems as tools to monitor and control quality.
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Labeling and packaging;
Production processes in bacterial and viral vaccines:
o Working seed, bulk formulation, filling and packaging;
o Products in development;
o Industrialization (scale-up);
o From idea to product.
Differences between vaccine and pharmaceutical production;
Inspections by authorities.
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Module IV
Infectious Diseases and Vaccine Prevention
Module Directors
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•
Prof. Roberto Gasparini - Director Public Health Department, University of Genoa, Italy
Dr. Audino Podda - Head Clinical Development & Regulatory Affairs, Novartis Vaccines
Institute for Global Health
Aim
To get familiar with the most important vaccine preventable infectious diseases from a clinical
and from a global epidemiological perspective.
To learn which vaccines are already available against these infectious diseases and which new
vaccines are being developed.
Contents
•
Bacterial diseases: clinical profile, epidemiology, and vaccines:
o Diphtheria
o Tetanus
o Pertussis
o Haemophilus influenza type b disease
o Meningococcal disease
o Pneumococcal disease
o Lyme disease/ Borreliosis
o Group A Streptococcal diseases
o Group B Streptococcal disease
o Staphylococcal disease
o Tuberculosis
o Helicobacter pylori infection
o Cholera
o Enterotoxigenic Escherichia coli
o Salmonellosis
o Shigellosis
o Others
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•
Viral diseases : clinical profile, epidemiology, and vaccines:
o Hepatitis A, B, C and E
o Measles
o Mumps
o Rubella
o Varicella & Zoster
o Influenza & Pandemic Influenza
o Respiratory syncytial virus
o Cytomegalovirus
o HIV/AIDS
o Tick Borne encephalitis
o Japanese encephalitis
o Yellow Fever
o Dengue Fever
o Rabies
o Human papillomavirus
o Herpes Simplex virus
o Rotavirus
o Others
•
Parasitic diseases: clinical profile, epidemiology, and vaccines:
o Malaria
o Others
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Module V
Clinical Development Methodology, Biostatistics and
Data Management
Module Directors
•
Dr. Stefania Rossi - Researcher of Public Health, Dept. of Molecular and Developmental
Medicine Area of Public Health, University of Siena, Italy
•
•
Dr. Giovanni Della Cioppa – Head Clinical Development Clusters, Novartis Vaccines
Dr. Uwe Nicolay - Head Biostatistics, Novartis Vaccines
Aim
To understand the basic principles of clinical trial methodology, especially in vaccine development.
To understand basic concepts of statistics and data management for clinical trials.
Contents
•
Overview of the clinical development:
o Clinical development plans;
o Phases of the clinical development process: Phase I - II - III - IV trials;
o Experimental studies (clinical trials) vs. epidemiological (observational) studies;
o Life-cycle of a product;
o Geographical, logistical & economic considerations.
•
Clinical trial methodology and protocol development:
o Why clinical trials? Variability of biological phenomena and measurement errors;
o Defining the treatment effect: from measurements to end-points;
o The choice of the sample: which subjects, how many subjects;
o The choice of treatments: study treatments, concomitant treatments;
o Experimental designs;
o The protocol approval processes: internal, external, amendments.
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•
Vaccine trial methodology:
o Safety, immunogenicity, efficacy and effectiveness;
o Surrogate end-points, correlates of protection and constrains of serological endo
points;
Ethical considerations in clinical development.
•
Statistical methodology for clinical trials:
o Basics, International Conference on Harmonization (ICH) guidelines (E8, E9, E10),
EMEA/FDA guidelines;
o Descriptive vs. inferential statistics;
o Importance of randomization to avoid bias;
o Power & sample size calculations for hypothesis testing;
o Superiority, equivalence, non-inferiority;
o Designs & analytical approaches;
o Endpoints (measures and variables), surrogate, markers;
o P-values: statistical and clinical significance;
o Statistical analysis plan;
o Interim analyses, meta analyses;
o Alignment of protocol, data collection and reports.
•
Clinical Data Management:
o Case Report Form (CRF) design;
o Electronic Data Capture and paper CRF processes and systems;
o Database design and setup with edit checks, rules and derivations;
o Validation of computerized systems for data management;
o Data collection and data cleaning;
o Data integration (e.g. lab data transfers);
o Data quality, database lock, post database lock changes;
o Adverse Event reporting;
o Coding dictionaries (Medical Dictionary for Regulatory Activities [MedDRA], WHOdrug).
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Module VI
Pharmacovigilance
Module Directors
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Prof. Franco Laghi Pasini - Professor of Internal Medicine and Director of Department of
Internal Medicine 2, University of Siena, Italy
•
Dr. Bernadette Hendrickx - VP, Senior Medical and Scientific Advisor to the CEO - Sanofi
Pasteur
•
Dr. Corinne Jouquelet-Royer - VP, Head Global Pharmacovigilance – Sanofi Pasteur
Aim
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.
Contents
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•
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Introduction to clinical safety, Pharmacovigilance and benefit-risk management;
•
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Safety data collection in clinical trials;
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Regulatory Reporting;
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Safety strategy, issue management and crisis prevention
Clinical safety in the Developing World;
Statutory basis for safety in humans:
o Historical basis;
o Governing bodies and Health Authorities: ICH, Council for International
Organizations of Medical Sciences (CIOMS), WHO;
Spontaneous adverse events;
Adverse Events:
o Definitions and classification;
o Processing, archiving and retrieval;
o Assessment: expectedness, listedness, causality and reference documents
o Analysis and decision-making;
Life-Cycle Clinical Product Safety:
o Discovery and pre-clinical science;
o Pre and post authorization clinical safety;
o Structured benefit-risk assessment and management
Communication in Pharmacovigilance
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IV Edition - 2015
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Module VII
Epidemiology, Health Systems and Health Economics
Module Directors
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Prof. Felice Petraglia – Professor of Obstetrics and Gynecology, Department of Molecular
and Developmental Medicine – University of Siena
•
Dr. John Weil - Head Epidemiology – Novartis Vaccines
Aim
To understand basic principles of Epidemiology and Health Economics and the relevance for
vaccine development.
Contents
•
Epidemiology:
o Principles of infectious diseases epidemiology;
o Measures of disease occurrence;
o Measures of impact;
o Sensitivity – specificity;
o Observational studies: cohort and case-control, alternative designs, how to write
a study protocol, choice of a reference group, synthesis causal inference,
sampling;
o Methodology: matching, bias, confounding, third factor, disentangling;
o Calculations - analysis: sample size calculation, significance, logistic regression;
o Surveillance: principles of surveillance, event based surveillance, analytical tools
in surveillance, lab-based surveillance, evaluation of surveillance.
•
Health Systems and Economics:
o Overview of key patterns and issues of health systems mainly in Low Income
Countries;
o Key concepts of the economics of health;
o Student will simulate tools for allocating resources in local health systems
assessing population health needs.
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Module VIII
Good Clinical Practice, Clinical Quality Assurance
and Clinical Trial Operations
Module Directors
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•
Prof. Stefano Gonnelli - Professor of Internal Medicine, University of Siena, Italy
Dr. Elisa Marchetti - Head Clinical Operations and Training, Novartis Vaccines Institute
for Global Health
Aim
To understand the requirements and to ensures quality in clinical trials execution and the
operational requirements for planning and executing vaccines clinical trials.
Contents
•
Introduction to Good Clinical Practice (GCP):
o Regulatory requirements, ICH and GCP and regional differences;
o Roles and responsibilities of sponsors, investigators and monitors;
o The importance of the Informed Consent;
o Essential documents.
•
Elements of the Clinical Quality System:
o Quality Policies and Quality Manual;
o Standard Operating Procedures (SOPs);
o Qualification and training of staff;
o Qualification of third parties (Contract Research Organizations CROs);
o Trial Master File;
o Auditing: internal and external auditing, system audits.
•
Regulatory inspections:
o Preparation of an inspection (sponsor and site);
o Types, procedure, reports;
o Frequent findings.
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IV Edition - 2015
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•
Introduction to Clinical Trial Operations (CTO):
o From protocol to clinical study report;
o Clinical project management & planning.
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Clinical trials preparation:
o Protocol, Informed Consent Form and related documents;
o Labeling & packaging of vaccines;
o Site qualification;
o Clinical research organizations (CRO);
o Documentation.
•
Clinical trial execution:
o Initiation visit;
o Monitoring;
o Safety;
o Study closure.
•
•
Database lock and close-out data management activities;
•
Clinical Study Report.
Operational systems and processes:
o Trial management systems;
o Efficiencies and quality control in process;
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IV Edition - 2015
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Module IX
Regulatory Affairs
Module Directors
•
Prof. Franco Laghi Pasini - Professor of Internal Medicine and Director of Department of
Internal Medicine 2, University of Siena, Italy
•
Dr. Anne-Marie Georges, Consultant, Biological Products Development and European
Pharmaceutical Law – Brussels, Belgium
•
Dr. Jochen Auerbach, Head Regulatory Affairs - Novartis Vaccines Institute for Global
Health
Aim
To understand international regulatory environment and requirements related to obtain approval
for vaccines and the maintenance of these licenses.
Contents
•
Introduction:
o General overview of main competent authorities (FDA, EMA, MHLW);
o International Conference on Harmonization (ICH).
o Drug development and life cycle from a regulatory perspective:
Preclinical;
Phase I – initial safety
Phase II – proof of concept, dose ranging;
Phase III – efficacy, large scale safety;
Regulatory constraints of serological endpoints;
Post Approval Commitments – studies to detect rare vaccine adverse
events, impact studies; epidemiology;
Health Authority review and approval procedures.
•
Regulatory systems:
o US regulatory system;
o EU regulatory system;
o WHO prequalification process;
o Other selected regulatory systems.
•
Product labeling:
o US Package Insert;
o EU Summary of Product Characteristics;
o Package inserts and labels, what needs to be included?
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•
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Regulatory differences between drugs and biologics;
Promotional compliance;
Regulatory Inspections
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IV Edition - 2015
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Module X
Policies and recommendations for vaccines in the world
Module Directors
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•
Prof. Paolo Bonanni - Department of Public Health, University of Florence
Dr. Audino Podda - Head Clinical Development & Regulatory Affairs, Novartis Vaccines
Institute for Global Health
Aim
To understand that the introduction of new vaccines into the immunization calendars of different
countries is dependent on a number of local and international factors.
Contents
•
Key elements of Vaccination Systems and Policies in different countries and
geographical areas:
o Vaccination systems: centralized vs. decentralized;
•
Policies for vaccine licensure, recommendation and implementation:
o data requested (epidemiological, clinical, economical etc.);
o Stakeholders & decision making process (WHO, UNICEF, PAHO, local and
Regional Technical Advisory Groups).
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•
•
•
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Factors influencing introduction of new vaccines;
•
Financing mechanisms: GAVI, AMCs, Bill & Melinda Gates Foundation, Revolving Fund,
PAHO, others.
Procedures for vaccine purchasing and supply;
Public acceptance of vaccination;
Health Technology Assessment (HTA) as a tool for prioritization;
Economic analysis applied to vaccination programs:
o Priority settings;
o National Immunization Committees;
o Vaccine schedules;
o National budgets;
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IV Edition - 2015
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IV Edition - 2015
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Special Topics
Aim
To provide tools for the students personal and professional growth.
First and second semester
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•
•
•
•
•
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How to read and interpret scientific papers;
How to write a clinical trial protocol and a protocol synopsis;
How to write an epidemiology protocol;
How to write grant applications and where to apply;
How to write a thesis;
How to write a paper to be published;
Presentation skills;
Communication: crisis management (clinical studies, SAEs, marketed products).
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IV Edition - 2015
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How to proceed
Entry Requirements
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•
University degree in Human Medicine;
Excellent command of English, written and spoken. The full Master Program is
conducted in English.
* Only ADITEC sponsored candidates must be:
•
•
Currently working in a European Union or Associated Member state or
Currently working in a vaccine development project funded by the European
Commission or EDCTP.
Funding
•
A 18-month grant will be provided to students who are accepted.
Application & Information
Application to the University of Siena
The IV Edition of the Master Program in Vaccinology will start on May 2015.
The Application process is explained in the University of Siena announcement (bando) that is
available at http://www.unisi.it/didattica/corsi-post-laurea/master-universitari (under the heading
“Master Executive”, courses are ordered by date). Candidates must send the official application
form to the University of Siena by February 05, 2015.
Assistance or further information to the candidates will be provided by Novartis Vaccines
Academy - Master Program Coordination. Please send an e-mail to
[email protected] by November 20, 2014
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IV Edition - 2015
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Contact information
Master Coordination: Mrs. Tiziana Musso, +39 0577 24 5253
Web: http://www.novartisvaccines.it/ricerca/clinical-development-eng.shtml
E-mail: [email protected]
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IV Edition - 2015
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Parts of this brochure can be updated at any time without a previous notice
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IV Edition - 2015
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