B8992 - PROFILASSI E TERAPIA IN CAMPO BIOMEDICO

Learning outcomes

By the end of the course, the student understands the principles of pharmacokinetics, pharmacodynamics, and the proper use of veterinary medicines, taking into account the drug’s origin, species differences, and regulatory aspects; is familiar with the fundamentals of biosafety and vaccine prophylaxis, the technologies for vaccine development, and the methodologies for testing their safety and efficacy.

Course contents

The course consists of two modules: Module 1 – Biomedical Prophylaxis (Prof. Caterina Lupini) and Module 2 – Biomedical Therapy (Instructor to be appointed).

MODULE 1 – Biomedical Prophylaxis (2 CFU, 16 hours)

• Principles of infectious disease prophylaxis, innate and adaptive immunity, and herd immunity (2 hours)
• Vaccine immunology: innate and adaptive immune responses, immunological memory, correlates of protection, and vaccine adjuvants (2 hours)
• Conventional vaccines: live attenuated, inactivated, toxoid, and subunit vaccines (2 hours)
• Next-generation vaccines: recombinant vaccines, viral vectors, DNA vaccines, mRNA vaccines, virus-like particles (VLPs), DIVA vaccines, and autogenous vaccines (3 hours)
• Biotechnological platforms for vaccine development and production: antigen identification, expression systems, cell culture technologies, formulation, quality control, and Good Manufacturing Practices (GMP) (3 hours)
• Preclinical and clinical evaluation of vaccines: safety, immunogenicity, efficacy, and pharmacovigilance (1 hour)
• European legislation governing veterinary immunological medicinal products and marketing authorization procedures (1 hour)
• Vaccination programmes, routes of administration, cold chain management, and factors influencing the immune response. Biosecurity in livestock farms, animal facilities, and biotechnology laboratories; integration of biosecurity, vaccination, and the One Health approach (2 hours)

MODULE 2 – Biomedical Therapy (3 CFU, 24 hours)

• Principles of pharmacokinetics, pharmacodynamics, and the responsible use of veterinary medicinal products, with particular reference to the different origins of medicinal products, species-specific differences, and regulatory aspects.

Readings/Bibliography

Teaching materials are available on the Virtuale Learning Environment.

Required reading

• Metwally S., El Idrissi A., Viljoen G. (Eds.). Veterinary Vaccines: Principles and Applications.

Recommended reading

• WOAH. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (latest edition).

Supplementary reading

• Recent scientific papers and review articles provided by the lecturer during the course.

Teaching methods

The course consists of lectures supported by multimedia presentations, discussion of case studies, critical analysis of the scientific literature, and presentation of practical examples related to the development, production, and use of veterinary medicinal products and vaccines. Real-life case studies concerning vaccination programs, biosafety strategies, and regulatory procedures for veterinary biological products will be discussed to encourage students' active participation.

No laboratory practical sessions are included.

Assessment methods

Examining lecturer: Prof. Caterina LupiniAssessment consists of a single written examination covering both modules of the course, designed to assess the achievement of the intended learning outcomes.

The examination includes 60 compulsory questions, distributed proportionally according to the ECTS credits assigned to each module:

• 36 questions on Module 2 – Biomedical Therapy (3 CFU);
• 24 questions on Module 1 – Biomedical Prophylaxis (2 CFU).

Questions consist of multiple-choice items (one correct answer only) and/or true/false questions.

At the end of the examination, 4 additional questions of greater complexity and integrative nature are included exclusively for the possible award of honours (cum laude).

Scoring

Compulsory questions

• Correct answer: +0.5 points;
• Incorrect answer: 0 points;
• No answer: 0 points.

The 60 compulsory questions allow students to obtain a maximum score of 30/30.

Honours questions

• Correct answer: +0.25 points;
• Incorrect answer: 0 points;
• No answer: 0 points.

The duration of the examination is 70 minutes.

The examination is passed with an overall score of at least 18/30, provided that the student achieves a passing score in both modules. To this end, students must obtain at least 60% of the available marks in each module of the compulsory section, corresponding to:

• at least 10.8/18 in Module 2 – Biomedical Therapy;
• at least 7.2/12 in Module 1 – Biomedical Prophylaxis.

Honours (30/30 cum laude) may be awarded to students who:

• obtain the maximum score of 30/30 in the compulsory questions; and
• correctly answer at least 3 of the 4 additional honours questions.

During the examination, the use of supporting materials or electronic devices, including books, notes, calculators, tablets, smartwatches, and computers, is not permitted.

With regard to the learning assessment, the use of AI is prohibited. Any use of AI constitutes a breach of academic integrity.

The results of the written examination will be published within five working days on the lecturer's Virtuale e-learning platform.

Examining lecturer: Prof. Caterina Lupini

Students can register for exams through the AlmaEsami platform (http://almaesami.unibo.it/ ). Exams are scheduled during the designated periods in the academic calendar. Additional sessions are available for students beyond the standard program duration.

Students with learning disorders and/or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students ) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives. 

Teaching tools

The course makes use of:

• PowerPoint presentations;
• Summary diagrams and concept maps;
• Scientific papers and up-to-date review articles;
• European regulatory documents and EMA and WOAH guidelines;
• Examples of regulatory dossiers and veterinary vaccine technical documentation;
• Teaching materials made available through the Virtuale Learning Environment.

Students requiring additional support are welcome to arrange an appointment with the lecturer via e-mail for clarification of course topics.

Office hours

See the website of Caterina Lupini

See the website of Anisa Bardhi