PHARMACEUTICAL RESEARCH AND DEVELOPMENT OF NEW MEDICINES AND VACCINES
| Title | ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΡΕΥΝΑ ΚΑΙ ΑΝΑΠΤΥΞΗ ΝΕΩΝ ΦΑΡΜΑΚΩΝ ΚΑΙ ΕΜΒΟΛΙΩΝ / PHARMACEUTICAL RESEARCH AND DEVELOPMENT OF NEW MEDICINES AND VACCINES |
| Code | ΦΔΑ2 |
| Faculty | Law |
| School | Law |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Winter |
| Common | No |
| Status | Active |
| Course ID | 600020839 |
Programme of Study: DPMS Farmakeutikó Díkaio (2022-sīmera)
Registered students: 27
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Compulsory Course | 1 | 1 | 6 |
| Academic Year | 2025 – 2026 |
| Class Period | Winter |
| Faculty Instructors |
|
| Instructors from Other Categories |
|
| Weekly Hours | 3 |
| Class ID | 600289305
|
Course Type 2021
General Foundation
Mode of Delivery
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600289305
Language of Instruction
- Greek (Instruction)
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)
This particular section mainly analyzes Regulation 536/2014 on clinical trials of medicinal products intended for humans, which introduces a pan-European licensing process through a new Clinical Trial Data Portal Gateway and distinguishes between clinical studies from clinical trials, as well as minimally invasive clinical trials. The basic guiding principles of this new EU initiative are interpreted in depth, exhaustively and multidisciplinary, such as the supremacy of participants' interests and respect for human rights (human dignity, integrity of person, rights of children and persons in need of increased protection, freedom of science) ensuring validity and reliability, the system of researcher or sponsor responsibility, which remains within the jurisdiction of the Member States and regulated by the respective national laws, the consent of participants or persons acting on their behalf, after thorough information, the protection of personal data. Special reference and analysis in this section will be made to the issue of clinical studies and trials of vaccines to deal with the Covid-19 pandemic from a legal, medical and bioethical point of view.
Keywords
preclinical studies and clinical trials, legal framework, bioethical issues
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
- Use of ICT in Student Assessment
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
