37236 - Drugs and Bioethics (A-K)

Course Unit Page

Academic Year 2018/2019

Learning outcomes

At the end of this course, students know:

- the main ethical issues in the clinical trials of drugs;

- principles regulating independent information on medicinal products;

- the problem of conflicts of interest in medical care and in research; how to identify and deal with conflicts of interest.

Course contents

- The main ethical issues in the clinical trials of drugs: preclinical vs clinical research; the role of ethics committees; relevant European framework.

- Principles regulating independent information on medicinal products, and sources to obtain independent information;

- Conflicts of interest in medical care and in research: definition; tools to identify potential conflicts and measures taken by review bodies and regulators.

Readings/Bibliography

It is essential to access the online material provided by the teacher (access restricted to UNIBO students). There is no need for specific textbooks.

Teaching methods

Lectures and interactive sessions.

Assessment methods

Oral examination to assess achievement of the skills detailed in the learning outcomes (see the Italian version for details)

Teaching tools

Teaching material can be downloaded through Moodle (access restricted to UNIBO students).

Office hours

See the website of Emanuel Raschi