Catholic University Medical School, Rome

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

Practical Information

Commencing Date:
Rome Italy

Teaching Methodology:
Credits :
(no credits defined)

European Fees:
3000 EUR
Scholarship Possibilities:

Course Contact

Lucia Lisi

+39 06 3051 4367


Office Link

Catholic University Medical School, Rome

University Accreditation: Yes

Centre of Excellence


This course 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.

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