| Course Type | Elective Course |
|---|
| Course Level | Bachelor's Degree |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 2 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learn the regulations about pharmacetical products, cosmetics and Medical Devices and learn the drug licensing procedures in Turkey, FDA and EMA
- Learn the licensing procedures for human medicinal products, preparing licesing dossier in CTD formating, and special licensing conditions.
- Learn the laws and regulations releated to cosmetics, cosmetic product decleration and product follow-up system
- Learn the regulations releated to medical devices, clasifications of medical devices, production and approval procedures
- Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life.
- Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | The course covers the regulations related to drugs, cosmetic products and medical devices. It also covers licensing procedures of orijinal, generic and special drugs, rules and regulations regarding cosmetics, product follow-up system and specifications , area of use and regulations regarding Medical devices. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Fundamental concepts regarding pharmaceutical products, cosmetics and medical devices |
|
2nd Week |
Drug licensing procedures in TİTCK, FDA and EMA |
|
3rd Week |
Preparing licensing dossier in CTD formating |
|
4th Week |
Licensing application procedures for orijinal and generic drugs (shortened application) |
|
5th Week |
Licensing applications on fast drugs and orphan drugs |
|
6th Week |
Variations licensed products and products during the licensing process |
|
7th Week |
ARA SINAV |
|
8th Week |
Rules and regulations about cosmetics, cosmetic product decleration |
|
9th Week |
Preparation of Product Information, Formulation Content and Finished Product dossiers, Product Tracking System |
|
10th Week |
Legislation regarding cosmetic products containing nanomaterial ; market surveillance and audit |
|
11th Week |
Medical Devices, basic definitions and their classifications |
|
12th Week |
ClassI, ClassIIa, ClassIIb, ClassIII type Medical Devices, their properties, area of usage and legislation releated to them |
|
13th Week |
Producer- seller- user duration in medical devices, production and confirmation process, Product Tracking System |
|
14th Week |
Licensing procedures on Traditional Herbal Medicinal Products |
|
| Recommended or Required Reading | 1. Lecturer notes
2. www.saglikbakanligi.gov.tr
3. www.titck.gov.tr
4. www.fda.gov
4. www.ec.eurpa.eu
5. www.who.in/medical-devices |
|---|
| Planned Learning Activities and Teaching Methods |
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
40 |
| Total(%) |
|
40 |
| Contribution of In-term Studies to Overall Grade(%) |
|
40 |
| Contribution of Final Examination to Overall Grade(%) |
|
60 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
2 |
2 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
1 |
14 |
| Preparation for Final exam |
1 |
8 |
8 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
6 |
6 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
1 |
5 |
5 |
| Total Work Load | 65 |
| Total Work Load / 30 (h) | 2.16 |
| ECTS Credit of the Course | 2 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
