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Catholic University Medical School, Rome

MSc Preclinical and Clinical Drug Development: Scientific, Regulatory and Ethical Aspects

Practical Information

Commencing Date :
tba
Language :
Italian
Location :
Rome Italy


Teaching Methodology :
Face-to-Face


European Fees :
3000 EUR
Scholarship Possibilities :
No

Course Contact

Catholic University Medical School, Rome

University Accreditation : Yes

Centre of Excellence

Description

The Catholic University of Sacred Heart, at the initiative of the Faculty of Medicine and Surgery "A. Gemelli" (in collaboration with the Society of Applied Pharmacological Sciences, SSFA, Viale Abruzzi 32-20131 Milano, Tel 02-29536444 - Fax 02-89058506 - E-mail: ssfaseg@tin.it ) for the academic year 2011/2012 establishing the second level University Master in "Development of preclinical and clinical drug: technical-scientific, regulatory and ethical." The second level university Master lasts one academic year for a total of 60 credits, equivalent to 1500 hours. The Master in "Development of preclinical and clinical drug: technical-scientific, regulatory and ethical" is intended to provide the tools for a cultural latest in-depth knowledge of the process of drug development processes and the related clinical trials. The availability of teachers coming not only from academia but also from different companies (national and multinational pharmaceutical industries based in Italy) and Italian Drug Agency will provide the most relevant information provided by experts directly involved 'in the field ', each in their own areas of expertise.

Covered Areas

Scientific Areas

PK/PD modelling Production technologies Target discovery and lead selection

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered


Modules

Module Title

Type

Duration

Credits

CPD

Preclinical and Clinical Drug Development: Scientific, Regulatory and Ethical Aspects Core 60