Regulatory affairs for the approval of medicines and clinical trials
| Title | Κανονιστικό πλαίσιο εγκρίσεως Φαρμάκων και κλινικών μελετών / Regulatory affairs for the approval of medicines and clinical trials |
| Code | ΠΜΣΒΦ-Μ7 |
| Faculty | Health Sciences |
| School | Pharmacy |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Winter/Spring |
| Coordinator | Aikaterini Markopoulou |
| Common | No |
| Status | Active |
| Course ID | 600023499 |
Programme of Study: P.M.S. Tmīmatos Farmakeutikīs "Viomīchanikī Farmakeutikī" (2023- )
Registered students: 30
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Compulsory Course | 3 | 2 | 6 |
| Academic Year | 2025 – 2026 |
| Class Period | Winter |
| Faculty Instructors | |
| Class ID | 600281911
|
Course Type 2021
General Foundation
Mode of Delivery
- Face to face
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600281911
- eLearning:
Learning Outcomes
By the end of the lessons, students will understand the regulatory framework applicable to new drug development processes, become familiar with the procedures and methodologies referred to early laboratory level of discovery, the pre-clinical and clinical evaluation with the execution of clinical trials and the dossier submission, marketing authorization and
pharmacovigilance.
Course Content (Syllabus)
• European and Greek pharmaceutical law. Regulatory framework for the approval and marketing of medicines.
• Good Manufacturing Practices (GMP). Systemic approach – regulatory compliance – practical application
• Purpose and principles of GMP – data integrity
• Regulatory framework for drug approval, general dossier requirements, specific requirements per category.
• Biosimilars and Orphan drugs.
• Health Technology Assessment, HTA (Health Technology Assessment).
• Contents of the EOF filing file - emphasis on detailed data.
• Configuration of a deposit file at the EOF
• Pharmacovigilance: regulatory framework and drug development.
• Introduction to Pharmacoepidemiology. Pharmacoepidemiological studies – Examples of developing and evaluating the use of approved drugs.
• Quality control in the pharmaceutical industry: regulatory framework. Analysis categories. Transfer of analytical data. Data integrity in the lab.
• Internal and external quality control inspections.
Educational Material Types
- Notes
- Slide presentations
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 | 108 | ||||
| Written assigments | 17 | ||||
| Exams | 3 | ||||
| Total | 128 |
Student Assessment
Student Assessment methods
- Written Exam with Multiple Choice Questions (Summative)
- Written Exam with Short Answer Questions (Summative)
- Written Exam with Extended Answer Questions (Summative)
- Written Assignment (Formative)
- Oral Exams (Formative)
- Written Exam with Problem Solving (Summative)
- Labortatory Assignment (Formative)
Last Update
28-02-2024
