Ateneo - UPO

The main ethical requirements for the marketing of the drug and for the choice of therapeutic indications will be examined. The principles that regulate the ethics of the clinical study and the ongoing evaluations of the activity and safety of the drug will be examined. Need for scientific research and approach to associated ethical dilemmas.

Computer material available on DIR.
Basic texts:
Pharmacology:principi di base e applicazioni terapeutiche, a cura di F. Rossi, V. Cuomo, C. Riccardi, Edizioni Minerva Medica
Le basi farmacologiche della terapia, Goodman e Gilman, Mc Graw-Hill
Farmacologia, Rang H.P., Dale M.M., Ritter J.M e Moore P.K., Casa Editrice Ambrosiana

The main purpose of the course is to provide an ethics for the development and use of drugs. To convey to the student the reasons for which there is a need for the advancement of knowledge through clinical research.
Lead the student to have the tools to evaluate the ethics of clinical studies and the approach to the patient.

Basic knowledge on biology and medicine.

Lectures and distance learning on D.I.R. with supporting PowerPoint presentations.

The teacher receives on Tuesday afternoon from 14 to 18, also via Meet. An e-mail appointment is welcome.

Verification will take place through a written test (open question). Time for completion 1 hour.

In order to assess knowledge and understanding, applied knowledge and understanding, independent judgement, communication skills, ability to learn, the test will be organized as follows.

Evaluation criteria:
- 25-30 points if exhaustive response, recognizes assistance needs/problems and knows how to handle them correctly
- 18-24 points partially comprehensive, partially recognizes care needs/problems and manages them not completely correctly
- < 18 points if not exhaustive, does not recognize assistance needs/problems and does not know how to manage them correctly

Bioethics: definitions and fundamental principles,
regulatory framework of reference.
Informed consent.
The right and dignity of the sick.
Peculiarities of the different phases of the experimentation and of the different fields
Roles of the ethics committee. Independence of the Ethics Committees from Industry and secularity in ethical decisions to guarantee the health of the patient.
Ethics of the use of placebo

Non-notional knowledge of the topics covered, the critical ability to tackle the topics transversally and to place knowledge in the context, ability to understand the correct ethical approach to the patient and to experimentation