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