LICENSING OF PHARMACEUTICAL PRODUCTS
| Title | ΑΔΕΙΟΔΟΤΗΣΗ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ / LICENSING OF PHARMACEUTICAL PRODUCTS |
| Code | ΦΔΑ3 |
| Faculty | Law |
| School | Law |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Winter |
| Common | No |
| Status | Active |
| Course ID | 600020840 |
Programme of Study: DPMS Farmakeutikó Díkaio (2022-sīmera)
Registered students: 23
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Compulsory Course | 1 | 1 | 6 |
| Academic Year | 2022 – 2023 |
| Class Period | Winter |
| Faculty Instructors | |
| Weekly Hours | 2 |
| Class ID | 600221396
|
Course Type 2021
General Foundation
Mode of Delivery
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600221396
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)
In this course, all the procedures for granting drug marketing authorizations, at national and European level, are presented and analyzed. Specifically, the Circular no. 38889/11-06-2008, the referred to the control procedure of compliance with the essential conditions for acquiring and maintaining the status of marketing authorization holder of medicinal products intended for human use, as well as the relevant competence of the E.O.F. At the same time, the procedure for obtaining the so-called European marketing authorization, which is provided for by Regulation no. 726/2004 (L 136/30.4.2004 p. 1-33), as well as the authorization at European level for other categories of medicines, such as for orphan medicines. The course also examines all the obligations of marketing authorization holders, as well as the responsibilities of committees that assist in the granting of licenses and the classification of medicines, such as the Evaluation Committee of Law 4512/2018.
Keywords
types of permits, conditions and procedure for granting them, indications and conditions of circulation
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
