The pharmatrain centres of
excellence in Italy
Rome, 11 June 2015
Pierlugi Navarra and Francesco de Tomasi
Master di II livello
Sviluppo preclinico e clinico del farmaco:
aspetti tecnico-scientifici, regolatori ed etici
‘Sviluppo preclinico e clinico del farmaco:
aspetti tecnico-scientifici, regolatori ed etici’
Contract with the Italian Drug Agency (AIFA).
Patronages by the italian association of drug industries and the Italian
Pharmacological Society.
PharmaTrain – centre of excellence
…meaning: pre-clinical and clinical drug
development. Scientific, regulatory and
ethics aspects
How this Master is organized:Based on the PharmaTrain Syllabus
∗ Introductory module / Principles of drug discovery / Non-clinical testing
∗ Pharmaceutical development / Drug development
∗ Clinical trials / Data management and Statistics
∗ Ethical and legal issues / Regulatory affairs
∗ Drug safety and Pharmacovigilance / Pharmacoepidemiology
∗ Pharmacoeconomics / Healthcare marketplace
� 2 elective modules: this year we choose..
� Generic & Biosimilar Medicinal Products
� Biological and Advanced Therapies
� 6 base modules
How this Master is organized:
∗ Face-to-face (F2F) lectures: 28 days (Friday and
Saturday morning, fram january to july every 2
weeks (150 hrs in total)
∗ pre-F2F and post-F2F learing (300 hrs in total)
∗ a Course of scientific and technical English
∗ Site visits at pharmaceutical plants in the area of
Rome
∗ Further bonus: free attendance to all SSFA activities
How this Master is organized:
∗ E-Learning. Access to E-learning PharmaTrain material
∗ Faculty: about 60 lectures each year, coming from Industry, CRO, Univesity and other public institutions (Italian DrugAgency, National Institute of Health, Ministry of Health, etc.)
∗ Stages at industries, CROs or public institutions (Italian DrugAgency, National Institute of Health, Ministry of Health)
∗ Ongoing assessments through MCQ at the end of eachModule, plus Thesis defense in October-November. Final vote summing the rate of responses to MCQ to the thesis’ vote
Requirements:
Degree in:
� Medicine and Surgery (Italian title for medicine),
� Pharmacy,
� Chemistry,
� Chemistry and Pharmaceutical technology (Italian specific)
� Veterinary medicine,
� Biology,
� Biotechnology,
� Economy (recently added..)
Academic Year Enrolled students
2007-2008 31
2008-2009 35
2009-2010 45
2010-2011 25
2011-2012 35
2012-2013 45
2013-2014 61
Total so far 275 diplomas
Current (2014-2015) 57
A balance of our work…
The balance from the students
∗ Costs: 3000 Euros;
∗ Students must attend to at
least 80% of F2F lectures
• II level (high-level..) Master
diploma;
• 60 CFU (also to be spent as CME)
• Certified Monitor (according to
the italian rules)
• Recognition in Europe
A follow-up questionnaire
A follow-up questionnaire
0
50
100
150
200
250
300
275 forms mailed
to past students