the pharmatrain centres of excellence in italy · the pharmatrain centres of excellence in italy...
TRANSCRIPT
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