| Course Type | Elective Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 5 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learn the drug licensing types and procedures in Turkey, FDA and EMA.
- Know to prepare CTD dossier.
- Know the registration procedure of human medicinal products, orphan drugs, biotechnological and biosimilar drugs
- Know the problems and solutions in the time of application of registration
- Use the accuired knowledge and skills in pharmaceutical industry and other instituions.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | The course covers; registration types in Turkey, EMA and FDA; Licensing (registration) procedures, duriation and Preparing licensing dossier in CTD formating. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Basic concepts of registration of drugs, |
|
2nd Week |
Registration types in Europien Medicines Agency (EMA)and registration procedures (Centralized National, Decentralized, Mutual Recognition ) |
|
3rd Week |
Registration types in Food Drug Administration (FDA)andregistration procedures (IND,NDA, ANDA) |
|
4th Week |
Registration procedures of original and generic drugs (shortened application), registration procedures for application |
|
5th Week |
Registration procedures in Turkey (TİTCK) |
|
6th Week |
Variations licensed products and products during the licensing process |
|
7th Week |
MIDTERM EXAMINATION |
|
8th Week |
Registration procedures for fast drug and orphan drugs |
|
9th Week |
Preparing licensing dossier in CTD formating, Module 1, Module 2 |
|
10th Week |
Preparing licensing dossier in CTD formating, Module 3, DMF (Drug Master File), quality information |
|
11th Week |
Preparing licensing dossier in CTD formating, Module 4, non clinical information |
|
12th Week |
Preparing licensing dossier in CTD formating, Module 4, non clinical information |
|
13th Week |
Preparing licensing dossier in CTD formating, Module 5, clinical information |
|
14th Week |
Registration Procedures of biotechnological and biosimilar |
|
15th Week |
Products (FDA,EMA,TİTCK guidelines) |
|
| Recommended or Required Reading | 1. Lecturer notes
2. www.titck.gov.tr
3. TİTCK, EMA,FDA, WHO Guidances |
|---|
| Planned Learning Activities and Teaching Methods |
- Lecture
- Discussion
- Questions/Answers
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
30 |
| Assignment |
2 |
20 |
| Total(%) |
|
50 |
| Contribution of In-term Studies to Overall Grade(%) |
|
50 |
| Contribution of Final Examination to Overall Grade(%) |
|
50 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
0 |
0 |
0 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
2 |
28 |
| Preparation for Final exam |
1 |
12 |
12 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
0 |
0 |
0 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
3 |
3 |
| Homework |
2 |
14 |
28 |
| Presentation (including preperation) |
1 |
14 |
14 |
| Literature review |
12 |
3 |
36 |
| Total Work Load | 149 |
| Total Work Load / 30 (h) | 4.96 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
