AIMS AND CONTENT

LEARNING OUTCOMES

Deepening of knowledge relating to the area of ​​the three-year degree course of In the field of Biomedical Laboratory Sciences and Techniques, deepening of knowledge relating to the area of ​​the three-year degree course of origin, and learning of the basic concepts of the areas of the other three-year degree courses pertaining to the Master's Degree course, class III, health professions, diagnostic techniques.origin, and learning of the basic concepts of the areas of the other three-year degree courses pertaining to the Master's Degree course class III health professions diagnostic techniques

AIMS AND LEARNING OUTCOMES

Understand organizational models for diagnostic and translational research laboratories.

· Apply tools for organizational analysis, monitoring, non-conformity management, and continuous improvement.

·  Understand the phases, regulations, and ethical principles of clinical trials and pharmaceutical development.

·  Classify epidemiological studies and analyze ethical aspects of clinical trials.

·  Advanced cytometry technologies for clinical analysis.

·  Study of omics in the medical field.

·  Introduction to Translational Medicine.

·  In-depth study of immunological diseases.

TEACHING METHODS

Lectures are delivered in person, and the course content will be presented through slides, which will be uploaded to aulaWeb after each class. Written and/or Oral exam.

Students with documented Specific Learning Disorders (SLD) or special educational needs are required to contact the Instructor(s) and the dedicated SLD Representative at the Department before the beginning of the course, in order to agree on specific teaching methods and ensure the proper achievement of learning objectives and outcomes.

SYLLABUS/CONTENT

Clinical Trials: Planning and Regulations

• Phases of clinical research trials: criteria of efficacy, quality, and safety.
• Fundamental principles: autonomy, beneficence, justice, and bioethics.
• Patients’ Bill of Rights; Ethics Committee; Informed consent.
• Requirements for proper clinical trials: relevant regulations; drug development process and its phases.
• Classification of epidemiological studies: observational vs. experimental; ethical issues; general structure of a clinical trial.
• Interpretation of clinical studies:
  • Reliability analysis: internal validity, endpoints, systematic errors, confidence intervals.
  • Clinical relevance analysis: external validity, clinical benefit, therapeutic efficacy.

Omics, Translational Medicine, and Immunological Diseases

• Clinical applications of omics sciences (genomics, proteomics, etc.).
• Introduction to Translational Medicine.
• Study of immune-mediated diseases: connective tissue disorders, ANA, lupus.

Laboratory Medicine as a Clinical Science

• Understanding the role of Laboratory Medicine as a clinical discipline providing essential information in the diagnostic and therapeutic process.
• Overview of the types and functions of different clinical laboratories.

Immunometric Techniques and Biomarkers

• Knowledge of main immunometric techniques for detecting antigens or antibodies: from non-tracer to tracer-based methods.
• Comparison between competitive and non-competitive assays.
• Analytical issues in immunoassays.
• Definition and clinical use of biomarkers.

Immune Response and Laboratory Evaluation

• Understanding of humoral and cell-mediated immune responses.
• Role of the clinical laboratory in evaluating immunopathological processes.

Tumor Immunology and Immunotherapy

• Key concepts in tumor immunology.
• Role of oncological immunotherapy as a new frontier in cancer treatment.

Plasma Proteins and Clinical Significance

• Types and roles of plasma proteins as indicators of organ function.
• Understanding how protein alterations reveal diseases and help monitor their progression.

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

II semester, I year

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam will include both oral and written components.

During the examination, the regulations established by the University for the evaluation of students with Specific Learning Disorders (SLD) or other special educational needs will be strictly followed.
These may include, for example:Extended time for written exams;The use of concept maps, which must be submitted for approval to the instructors at least one week prior to the exam date.

ASSESSMENT METHODS

he basic elements of the subject must be known in order for the exam to be considered sufficient