LEGISLAZIONE ED AMMINISTRAZIONE FARMACEUTICHE - ECONOMIA E GESTIONE DI IMPRESAModule LEGISLAZIONE ED AMMINISTRAZIONE FARMACEUTICHE
Academic Year 2026/2027 - Teacher: ROSARIO PIGNATELLOExpected Learning Outcomes
This course aims to provide students with both fundamental and in-depth knowledge regarding the professional, financial, and asset management of community pharmacies, with reference to current Italian and EU regulations governing pharmaceutical services and a particular focus on the new rules concerning the "pharmacy of services" model.
1. Knowledge and Understanding
At the end of the course, students will be able to:
Demonstrate knowledge of the fundamental principles of national and European pharmaceutical legislation governing medicinal products, medical devices, and healthcare products.
Understand the institutional and regulatory framework of the pharmaceutical sector, including the roles of regulatory authorities.
Describe the procedures for marketing authorization of medicinal products and the related legal requirements.
Explain the regulatory provisions governing the manufacture, distribution, prescription, dispensing, and pharmacovigilance of medicinal products.
Understand legal and ethical aspects related to clinical trials, public health protection, and pharmacists' professional responsibilities.
2. Applying Knowledge and Understanding
At the end of the course, students will be able to:
Apply pharmaceutical legislation and regulatory requirements to practical and professional situations.
Interpret legal, regulatory, and administrative documents relevant to pharmaceutical practice.
Assess compliance of pharmaceutical activities and procedures with current regulations.
Use regulatory instruments to address issues related to the management, storage, and dispensing of medicinal products.
Analyze case studies involving pharmacovigilance, traceability, and drug safety.
3. Making Judgements
At the end of the course, students will be able to:
Critically evaluate the application of pharmaceutical legislation in professional practice.
Identify the legal, ethical, and professional implications of decisions made within the pharmaceutical field.
Assess the impact of regulatory developments on public health and pharmaceutical services.
Evaluate risks and liabilities arising from non-compliance with applicable legislation.
4. Communication Skills
At the end of the course, students will be able to:
Use appropriate legal and regulatory terminology in the pharmaceutical field.
Communicate legislative and regulatory information effectively to healthcare professionals, patients, and competent authorities.
Justify professional decisions by referring to relevant legal and regulatory frameworks.
Participate in interdisciplinary discussions on pharmaceutical regulation and public health issues.
5. Learning Skills
At the end of the course, students will be able to:
Independently identify and consult legal, regulatory, and scientific sources relevant to pharmaceutical legislation.
Continuously update their knowledge in response to changes in national and international pharmaceutical regulations.
Explore emerging issues in pharmaceutical regulation, innovation, and healthcare governance.
Integrate legal, scientific, and professional knowledge to address novel and complex challenges.
Engage in lifelong learning and continuing professional development within the pharmaceutical and healthcare sectors.
Course Structure
Classes will be held in person, featuring the presentation and discussion of teaching materials; supplementary professional-development seminars may also be scheduled. Should the course be delivered in a hybrid format (combining in-person and remote learning), necessary adjustments to the previously stated arrangements may be introduced to ensure the planned curriculum outlined in the syllabus is covered.
For the Economics module, teaching will primarily take place synchronously in an interactive virtual classroom, incorporating role-playing exercises and simultaneous tests to guide student learning.
In accordance with the Academic Regulations (RDA), Art. 12 – University Educational Credits (CFU), the standard student workload of 25 total hours per credit comprises 7 hours of lectures or equivalent teaching activities, with the remainder dedicated to independent study.
Students may use AI as a study aid, provided they comply with applicable regulations—including those regarding copyright and the use of intellectual works, as detailed in section 5.1 of the guidelines.
For the Economics module, teaching will primarily take place synchronously in an interactive virtual classroom, incorporating role-playing exercises and simultaneous tests to guide student learning.
In accordance with the Academic Regulations (RDA), Art. 12 – University Educational Credits (CFU), the standard student workload of 25 total hours per credit comprises 7 hours of lectures or equivalent teaching activities, with the remainder dedicated to independent study.
Students may use AI as a study aid, provided they comply with applicable regulations—including those regarding copyright and the use of intellectual works, as detailed in section 5.1 of the guidelines.
Required Prerequisites
Students must have a background in pharmacology and pharmaceutical technology.
Attendance of Lessons
Attendance is mandatory in accordance with the Degree Programme regulations (at least 70% of the lessons).
Information for students with disabilities and/or specific learning disorders (SLD)
To ensure equal opportunities and compliance with current legislation, interested students may request a personal meeting to arrange any necessary compensatory measures and/or dispensations, based on educational objectives and specific needs.
Students may also contact the Department’s designated representative for CInAP (Centre for Active and Participatory Integration – Services for Disabilities and/or SLD), Prof. Santina Chiechio.
Information for students with disabilities and/or specific learning disorders (SLD)
To ensure equal opportunities and compliance with current legislation, interested students may request a personal meeting to arrange any necessary compensatory measures and/or dispensations, based on educational objectives and specific needs.
Students may also contact the Department’s designated representative for CInAP (Centre for Active and Participatory Integration – Services for Disabilities and/or SLD), Prof. Santina Chiechio.
Learning Assessment
Learning Assessment Procedures
Written test featuring open-ended and randomized multiple-choice questions, each with a clearly indicated, variable point value; a supplementary oral exam may be held at the student's request.
Assessment may also be conducted online, should circumstances require it.
The final grade will be based on the weighted average of the two modules comprising the course.
Information for students with disabilities and/or specific learning disorders (SLD)
To ensure equal opportunities and compliance with current regulations, interested students may request a personal meeting to plan any compensatory and/or dispensatory measures, based on educational objectives and specific needs.
Students may contact Prof. Santina Chiechio, the designated representative for the Department of Drug and Health Sciences for CInAP (Center for Active and Participatory Integration – Services for Disabilities and/or SLD – https://www.cinap.unict.it).
Exam dates are published on the Degree Course website: https://www.dsf.unict.it/corsi/lm-13
ASSESSMENT CRITERIA
The final exam will be evaluated based on equally weighted indicators aligned with the expected learning outcomes (Dublin Descriptors):
- capacity for independent analysis and operational initiative;
- ability to consult and utilize bibliographic material;
- scientific understanding of the subject matter.
Therefore, the final grade takes into account the various factors listed below. Quality of knowledge, skills, and competencies possessed and/or demonstrated:
a) appropriateness, accuracy, and consistency of knowledge
b) appropriateness, accuracy, and consistency of skills
c) appropriateness, accuracy, and consistency of competencies
Based on the above, the assessment may be:
a) Exam not passed: the student does not possess the minimum required knowledge of the course's core content. The ability to use specialized terminology is extremely poor or non-existent, and the student is unable to independently apply the knowledge acquired.
b) Sufficient (grade 18 to 20/30): the student demonstrates limited acquisition of concepts, a superficial level of learning, and significant gaps in knowledge. Expression skills are modest but sufficient to sustain a coherent dialogue; logical reasoning and the ability to connect topics are at an elementary level; there is poor capacity for synthesis and rather labored graphic expression; interaction with the instructor during any oral discussion is limited.
c) Fair (21 to 23/30): the student demonstrates a fair grasp of concepts but limited depth of understanding, with few gaps; acceptable command of scientific terminology; logical reasoning and ability to connect topics of moderate complexity; more-than-sufficient capacity for synthesis and acceptable graphic expression.
d) Good (24 to 26/30): the student demonstrates a broad knowledge base and moderate depth of understanding, with only minor gaps; satisfactory expression skills and significant command of scientific terminology; clearly evident critical thinking; good capacity for synthesis and more-than-acceptable graphic expression. e) Very Good (27 to 29/30): the student demonstrates an extensive and in-depth knowledge base, with only minor gaps; remarkable expressive skills and a high level of mastery regarding scientific terminology; strong competence and a notable aptitude for logical synthesis; and a high capacity for synthesis and graphic representation.
f) Excellent (30/30): the candidate demonstrates a very extensive and in-depth knowledge base, with any gaps being negligible; high expressive skills and a high level of mastery regarding scientific terminology; a marked aptitude for drawing connections between different topics; and excellent synthesis skills combined with great proficiency in graphic representation.
Honours (*cum laude*) are awarded to candidates who perform well above average and whose limitations—whether regarding knowledge, expression, conceptual understanding, or logic—are, on the whole, entirely negligible.
Assessment may also be conducted online, should circumstances require it.
The final grade will be based on the weighted average of the two modules comprising the course.
Information for students with disabilities and/or specific learning disorders (SLD)
To ensure equal opportunities and compliance with current regulations, interested students may request a personal meeting to plan any compensatory and/or dispensatory measures, based on educational objectives and specific needs.
Students may contact Prof. Santina Chiechio, the designated representative for the Department of Drug and Health Sciences for CInAP (Center for Active and Participatory Integration – Services for Disabilities and/or SLD – https://www.cinap.unict.it).
Exam dates are published on the Degree Course website: https://www.dsf.unict.it/corsi/lm-13
ASSESSMENT CRITERIA
The final exam will be evaluated based on equally weighted indicators aligned with the expected learning outcomes (Dublin Descriptors):
- capacity for independent analysis and operational initiative;
- ability to consult and utilize bibliographic material;
- scientific understanding of the subject matter.
Therefore, the final grade takes into account the various factors listed below. Quality of knowledge, skills, and competencies possessed and/or demonstrated:
a) appropriateness, accuracy, and consistency of knowledge
b) appropriateness, accuracy, and consistency of skills
c) appropriateness, accuracy, and consistency of competencies
Based on the above, the assessment may be:
a) Exam not passed: the student does not possess the minimum required knowledge of the course's core content. The ability to use specialized terminology is extremely poor or non-existent, and the student is unable to independently apply the knowledge acquired.
b) Sufficient (grade 18 to 20/30): the student demonstrates limited acquisition of concepts, a superficial level of learning, and significant gaps in knowledge. Expression skills are modest but sufficient to sustain a coherent dialogue; logical reasoning and the ability to connect topics are at an elementary level; there is poor capacity for synthesis and rather labored graphic expression; interaction with the instructor during any oral discussion is limited.
c) Fair (21 to 23/30): the student demonstrates a fair grasp of concepts but limited depth of understanding, with few gaps; acceptable command of scientific terminology; logical reasoning and ability to connect topics of moderate complexity; more-than-sufficient capacity for synthesis and acceptable graphic expression.
d) Good (24 to 26/30): the student demonstrates a broad knowledge base and moderate depth of understanding, with only minor gaps; satisfactory expression skills and significant command of scientific terminology; clearly evident critical thinking; good capacity for synthesis and more-than-acceptable graphic expression. e) Very Good (27 to 29/30): the student demonstrates an extensive and in-depth knowledge base, with only minor gaps; remarkable expressive skills and a high level of mastery regarding scientific terminology; strong competence and a notable aptitude for logical synthesis; and a high capacity for synthesis and graphic representation.
f) Excellent (30/30): the candidate demonstrates a very extensive and in-depth knowledge base, with any gaps being negligible; high expressive skills and a high level of mastery regarding scientific terminology; a marked aptitude for drawing connections between different topics; and excellent synthesis skills combined with great proficiency in graphic representation.
Honours (*cum laude*) are awarded to candidates who perform well above average and whose limitations—whether regarding knowledge, expression, conceptual understanding, or logic—are, on the whole, entirely negligible.
Examples of frequently asked questions and / or exercises
Staffing plan and its revision
Presidential Decree (DPR) 309/90 and subsequent amendments and additions
Veterinary prescriptions
Formal and informal substitution of the pharmacy owner
. Administrative classification of medicinal products pursuant to Law 219/2006
Outline the contents of the Italian Official Pharmacopoeia tables
Presidential Decree (DPR) 309/90 and subsequent amendments and additions
Veterinary prescriptions
Formal and informal substitution of the pharmacy owner
. Administrative classification of medicinal products pursuant to Law 219/2006
Outline the contents of the Italian Official Pharmacopoeia tables