POST-APPROVAL MONITORING OF THE SAFETY AND EFFECTIVENESS OF MEDICINES
| Title | ΜΕΤΕΓΚΡΙΤΙΚΗ ΠΑΡΑΚΟΛΟΥΘΗΣΗ ΤΗΣ ΑΣΦΑΛΕΙΑΣ ΚΑΙ ΑΠΟΤΕΛΕΣΜΑΤΙΚΟΤΗΤΑΣ ΤΩΝ ΦΑΡΜΑΚΩΝ / POST-APPROVAL MONITORING OF THE SAFETY AND EFFECTIVENESS OF MEDICINES |
| Code | ΦΔΒ5 |
| Faculty | Law |
| School | Law |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Spring |
| Common | No |
| Status | Active |
| Course ID | 600020847 |
Programme of Study: DPMS Farmakeutikó Díkaio (2022-sīmera)
Registered students: 23
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Compulsory Course | 2 | 1 | 6 |
| Academic Year | 2022 – 2023 |
| Class Period | Spring |
| Class ID | 600228220
|
Course Type 2021
General Foundation
Mode of Delivery
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600228220
Language of Instruction
- Greek (Instruction, Examination)
Learning Outcomes
Development of the ability to recognise und understand the main interpretative issues related to the taught provisions, to use appropriate interpretative methods for solving them, to present und critically evaluate the opinions supported about them in science and jurisprudence and to apply correctly the provisions in the framework of practical exercises.
General Competences
- Apply knowledge in practice
- Retrieve, analyse and synthesise data and information, with the use of necessary technologies
- Adapt to new situations
- Make decisions
- Work autonomously
- Work in teams
- Work in an international context
- Work in an interdisciplinary team
- Generate new research ideas
- Design and manage projects
- Appreciate diversity and multiculturality
- Respect natural environment
- Be critical and self-critical
- Advance free, creative and causative thinking
Course Content (Syllabus)
The so-called pharmacovigilance is the continuous monitoring and control of the drugs and in particular the side effects of taking them from the moment of their marketing authorization until their final withdrawal from the market and is guaranteed by a strict relevant legislation. In this section, all the legal consequences of the circulation of defective medicines are examined in depth, the concept of defectiveness is defined, relevant judicial decisions are presented and commented on regarding the attribution of civil liability, based on article 6 of Law 2251/1994, as well as the relevant regulations of the Civil Code, as well as matters of criminal liability from the circulation of counterfeit medicines or medicines that do not meet the terms and conditions of legal circulation.
Keywords
principles of pharmacovigilance, recording of adverse events, legal framework and related liability, data management in digital and non-digital applications, civil and criminal liability
Educational Material Types
- Notes
- Slide presentations
- Video lectures
- Audio
- Multimedia
- Interactive excersises
- Book
Use of Information and Communication Technologies
Use of ICT
- Use of ICT in Course Teaching
- Use of ICT in Laboratory Teaching
- Use of ICT in Communication with Students
Course Organization
| Activities | Workload | ECTS | Individual | Teamwork | Erasmus |
|---|---|---|---|---|---|
| Lectures | 39 | ||||
| Seminars | 12 | ||||
| Reading Assigment | 73.5 | ||||
| Written assigments | 60 | ||||
| Exams | 3 | ||||
| Total | 187.5 |
Student Assessment
Description
Written or oral examination at the end of the semester on the subject-matter covered during lectures and seminars.
Evaluation of a written assignment (paper) on a topic selected by each student.
Student Assessment methods
- Written Exam with Extended Answer Questions (Formative)
- Written Assignment (Formative)
- Oral Exams (Formative)
Bibliography
Course Bibliography (Eudoxus)
Βιβλία, άρθρα και μονογραφίες για το αντικείμενο του μαθήματος.
Additional bibliography for study
Επιπρόσθετη βιβλιογραφία καθώς και άλλο βοηθητικό υλικό (διαγράμματα παραδόσεων, πρακτικά παραδόσεων, αποφάσεις νομολογίας, φροντιστηριακές ασκήσεις, σεμιναριακό υλικό) παρέχεται κατά τη διάρκεια των μαθημάτων από τον εκάστοτε διδάσκοντα / διδάσκουσα ή αναρτάται στο e-learning.
Last Update
25-11-2023
