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 aim of the course is to provide the ethical basis for the development and use of drugs. Furthermore, the course aims to provide knowledge and understanding and the ability to apply basic knowledge relating to the ethics of drug testing.
Another objective of the course is to convey to the student the reasons why there is a need to advance knowledge through clinical research.
Provide the student with the tools to evaluate the ethics of clinical studies and the approach to the patient.
The general objective is to enable the student to develop independent judgement, communication skills and learning ability for this subject.

Basic knowledge on biology and medicine.

Lectures and distance learning on D.I.R. with supporting PowerPoint presentations.
Students will be actively involved in the learning process and in the development of a critical spirit through clinical examples and computer simulations in the classroom.
Particular attention will be paid to the adoption of gender language and information for students with disabilities, with Specific Learning Disorders (DSA), with Special Educational Needs (BES).

The teacher receives on Tuesday afternoon from 14 to 18, also via Meet. An e-mail appointment is welcome. Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services- students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

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.
The course program includes addressing issues relating to the integration of the gender dimension, in particular with reference to the therapeutic management of patients and the behavior of healthcare personnel in this area.

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 At the end of the course, the student will be able to: i) critically support the patient during drug treatments to reduce the risks, ii) appreciate the importance of pharmacology for improving health. Knowledge and Understanding: Students are expected to have demonstrated knowledge and understanding in their field of study, including some cutting-edge topics. Furthermore, they are expected to have demonstrated knowledge and understanding that extend and strengthen those typically possessed at this level of education, and that may enable them to develop and/or apply original ideas, often in a research context. Ability to Apply Knowledge and Understanding: Students are expected to be able to apply their knowledge and understanding in a manner that demonstrates a professional approach to their work and possess adequate skills to both develop and sustain arguments and solve problems in their field of study. Furthermore, they are expected to be able to apply their knowledge, understanding, and problem-solving skills to new or unfamiliar topics within broader (or interdisciplinary) contexts related to their field of study. Independent judgment: Students are expected to have the ability to collect and interpret data (usually within their field of study) deemed useful for making independent judgments, including reflection on related social, scientific, or ethical issues. They are also expected to have the ability to integrate knowledge and manage complexity, as well as formulate judgments based on limited or incomplete information, including reflection on the social and ethical responsibilities associated with the application of their knowledge and judgments. Students must be capable of critical analysis, evaluation, and synthesis of new and complex ideas. Communication skills: Students are expected to communicate information, ideas, problems, and solutions to both specialist and non-specialist audiences, and to communicate their conclusions, as well as the knowledge and rationale behind them, clearly and unambiguously. Furthermore, students must be able to communicate with their peers, the broader scholarly community, and society at large in their fields of expertise. Learning skills: Students are expected to have developed the learning skills necessary to undertake further studies with a high degree of autonomy, to have developed the learning skills that allow them to continue studying largely self-directed or autonomously, and to be capable of promoting, in academic and professional contexts, technological, social, or cultural advancement in the knowledge-based society.