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Drs. Rappuoli, Clemens and Saul will also be part of the Faculty and will give lectures during the Masters.
Several heads of global departments within Novartis Vaccines & Diagnostics (NVD) and the Novartis
Vaccines Institute for Global Health (NVGH) are assigned as the Module Directors and will be respon-
sible for the content and design of each module and for the liaison with the University of Siena.
Additionally, many scientists from the international Novartis Vaccines staff and from the University of
Siena will be invited to be part of the Faculty and to contribute to the teaching program in their area
of expertise. Among them: Prof. Heinz-Josef Schmitt (Medical Affairs), Dr. John Ferguson (Pharmaco-
vigilance), Dr. Theodore Tsai (Scientific Affairs), Dr. Klaus Stöhr (Influenza), Dr. Peter Dull (Meningitis),
Dr. Uwe Nicolay (Biostatistics), Dr. Luiz Jacintho Da Silva (Epidemiology) and others.
Keystone lectures will be delivered by a selection of eminent guest speakers, with international repu-
tation in vaccine development. The following have already agreed to participate: Prof. Robert Steffen
(University of Zurich, Switzerland), Prof. Frank von Sonnenburg (University of Munich, Germany),
Prof. Paul-Henry Lambert (University of Geneva, Switzerland), Dr. Roland Dobbelaer (former chair
of the EMEA Vaccine Working Party, Belgium), Dr Manfred Haase (former member of EMEA CHMP
and Director of the Paul-Erlich-Institute, Germany), Prof. Joel Ward (UCLA, U.S.A.), Prof. Pietro Crovari
(University of Genova, Italy), Prof. Roberto Gasparini (University of Genova, Italy), Prof. Susanna
Esposito (University of Milan, Italy), Prof. Paolo Bonanni (University of Florence, Italy), Prof. Giovanni
Gabutti (University of Ferrara, Italy), Dr. Anne-Marie Georges (AMQuidPharma, Belgium), Prof. Karl
Nicholson (University of Leicester, U.K.), Prof. Juhani Eskola (National Public Health Institute (KTL),
Finland), Prof. Fred Zepp (University of Mainz, Germany), Prof. Donato Greco (Istituto Superiore di
Sanità, Italy) and Dr. Daniel Brasseur (Chair of the EMEA Pediatric Committee, Belgium).
TECHNICAL-Scientific Committee:
Prof. Gianni Rossolini (University of Siena),
Dr. Audino Podda and Dr. Giovanni Della Cioppa (Novartis Vaccines & .Diagnostics)
Organisation:
Benedetta Caselli (Human Resources, Novartis Vaccines & Diagnostics)
ORGANISED BY
Funding.......................................................................................................................................................................................................3
Regulatory affairs.....................................................................................................................................................................9
First references to the university of Siena date back to 1240, making it one of the most
ancient academic institutions in Europe. In 1357 Emperor Charles IV, in a document
issued in Prague, included Siena among the official universities of the Holy Roman
Empire. Today, the University of Siena runs a wide selection of graduate and postgraduate
courses, including doctoral degree programmes, specialization schools and masters
programmes.
FUNDING
A 2-year grant will be provided to students who are accepted.
* Please make sure that your curriculum vitae contains details of your
command of the English language, specifying courses attended (including
those in Medical School) and the level reached by examination.
Contact person:
ACADEMIC CALENDAR
Masters in Vaccinology & Pharmaceutical Clinical Development | page 5
Content:
Serology
- Antibody response and correlates of protection
- Functional assays versus quantitative assays
Method of working: Lectures (32 hours), self-study, practical and written assignments, tests etc.
(68 hours)
Evaluation: During module: Written assignments
End of module: Written tests
End of year: Written and oral examination.
Masters in Vaccinology & Pharmaceutical Clinical Development | page 7
Content:
Organisation
- Procedures and flows in manufacturing and control vaccines
- Plant structure & layout, shifts
Quality - throughout the process - the importance of Good Manufacturing Practices (GMP)
to guarantee an immunogenic and safe product
- Selection of raw materials
- Systems as tools to monitor and control
Method of working: Lectures (24 hours), self-study, visits to manufacturing facilities, practical and
written assignments, tests etc. (51 hours)
Evaluation: End of module: Written examination
End of year: Written and oral examination
page 8 | Masters in Vaccinology & Pharmaceutical Clinical Development
Content:
Overview of the clinical development process
- Clinical development plans
- Phases of the clinical development process: Phase I - II - III - IV trials
- Experimental studies (clinical trials) vs. epidemiology (observational) studies
- Safety, immunogenicity, efficacy
- Life-cycle management of a product
- Geographical, logistical & economical considerations
Clinical trial methodology and protocol development
- Why clinical trials? Variability of biological phenomena and measurement errors
- Defining the treatment effect
- The choice of the sample: which subjects, how many subjects
- The choice of treatments: study treatments, concomitant treatments
- Experimental designs
- The protocol approval processes: internal, external, amendments
Ethical considerations in clinical development
Health economics considerations in clinical development
Clinical study reports
- Content
- Report writing principles
- Quality control and approval processes: internal, external
Safety reporting and pharmacovigilance
- Risk-benefit assessments
- Adverse Events (AEs), Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse
Reactions (SUSARs)
- Expedited reporting, annual safety reports to regulatory authorities.
Pitfalls & challenges in clinical development
- Cost-benefit, logistical issues, patents, competition, supply problems, seasonal vaccines, etc.
Recommended Reading: “Fundamentals on clinical research. Bridging medicine, statistics and
operations” by Antonella Bacchieri & Giovanni Della Cioppa
Publisher: Springer-Verlag, 2007
Method of working: Lectures (40 hours), self-study, practical assignments in Clinical
Development teams, business training, tests etc. (85 hours)
Evaluation: During module: Written assignments
End of module: Written tests
End of year: Written and oral examination.
Masters in Vaccinology & Pharmaceutical Clinical Development | page 9
Regulatory Affairs
Module: 6 Credits: 3 Semester: 1
Duration: 75 hours, distributed over 4 weeks, simultaneously with module 5 ‘Clinical
Development & Methodology’
Module Directors: Edward Thomas Reilly, Head Regulatory Affairs for Europe & International, NVD
Hillel Cohen, Head Regulatory Affairs for the Americas
& Head Regulatory Affairs for Early Development, NVD
Aim: Students will understand the international regulatory environment and detailed requirements
related to obtaining approval for marketing vaccines and the maintenance of these licences.
Content:
Introduction
- General overview of main Competent Authorities (FDA, EMEA, MHLW)
- International Conference on Harmonisation (ICH)
Regulatory systems
- US regulatory system
- EU regulatory system
- Other selected regulatory systems
Product Labeling
- US Package Insert
- EU Summary of Product Characteristics
- Package Inserts and labels, what needs to be included
Promotional activities
Regulatory inspections
Method of working: Lectures (24 hours), self-study, practical and written assignments, tests,
etc. (51 hours)
Evaluation: During module: Written assignments
End of module: Written tests
End of year: Written and oral examination.
page 10 | Masters in Vaccinology & Pharmaceutical Clinical Development
Aim: Students will understand the full ICH-GCP requirements and will be able to apply them to
vaccines clinical trials performed by sponsor companies and by investigators internationally.
Content:
Regulatory inspections
- Preparation of an inspection (sponsor and site)
- Types, procedure, reports
- Frequent findings
Method of working: Lectures (16 hours), self-study, GCP training*, practical and written
assignments, tests, etc. (34 hours)
Introduction
- From protocol to clinical study report
- Clinical project management & planning
End of trial
- Data review and database lock
- Site close-out
- Clinical study report
Documentation
- Essential documents, Trial Master File, document management, archiving
Method of working: Lectures (32 hours), self-study, practical and written assignments, tests, etc.
(68 hours)
Evaluation: During module: Written assignments
End of module: Written tests
End of year: Written and oral examination.
Masters in Vaccinology & Pharmaceutical Clinical Development | page 13
Aim: Students will learn that the introduction of new vaccines into the immunisation calendars of
different countries is dependent on a number of international and local factors
Content:
Health economics
Method of working: Lectures (24 hours), self-study, written assignments, tests, etc. (51 hours)
University of Siena:
http://www.unisi.it/internet/home.html
Go to
> Cost of Living in Siena, Italy
> Health services and Insurance
> Medical facilities
> Meals Sports & leisure facilities
> Local Transportation
Accomodation
http://www.unisi.it/v0/minisito.html?fld=1782
Email: vaccines_master.nvdit@novartis.com
See website:
MASTER http://www.unisi.it/postlaurea/master.htm
UNIVERSITARI
Citizens from outside the European Union, with legal residence permit in Italy,
please also include:
• Photocopy of valid visa and permit to stay in Italy
Citizens from outside the European Union, resident outside the European Union
• Please present your application to the Italian Embassy or Consulate in your
country of origin (or current country of residence), who will support you with
compiling, translating and validating the documentation and who will submit
your application to the University of Siena.
For further information concerning applications, please consult the university website:
http://www.unisi.it/ammin/udss/affari_generali/stranieri_english.htm
Citizens from outside of the European Union, with legal residence permit in Italy
Citizens from outside of the European Union who are residents abroad
Email: vaccines_master.nvdit@novartis.com