The history, content, methods, types, international and national rules of clinical research, good clinical practice system (GCP), relevant regulations taught by working theoretically. The course is full with heavy readings and assignment.
Vertical Tabs
Course Learning Outcomes
Learning Outcomes |
Programme learning outcomes |
Teaching Methods |
Assessment Methods |
1) Describe the definition of management and management functions |
1,5 |
1,2,3,4,8 |
A,F,G,H |
2) Explains the motivation theories |
1,5 |
1,2,3,4,8 |
A,F,G,H |
3) Knows how to do SWOT analysıs |
1,5 |
1,2,3,4,8 |
A,F,G,H |
4) Knows how to assess time management in pharmacoeconomics research and services |
1,5 |
1,2,3,4,8 |
A,F,G,H |
5) Knows financial management and relations with pharmacoeconomics and politics |
1,5 |
1,2,3,4,8 |
A,F,G,H |
Course Flow
Week |
Teorical Topics |
Practice content |
Study Materials |
1 |
History |
|
|
2 |
Helsinki Declaration |
|
|
3 |
ICH-GCP guideline |
|
|
4 |
ICH-GCP guideline |
|
|
5 |
GCP (EMA Application) |
|
|
6 |
GCP (FDA Application) |
|
|
7 |
GCP (Turkey (TR) Application) |
|
|
8 |
Regularity applications about clinical reseraches |
|
|
9 |
Ethics in clinical trials
|
|
|
10 |
Types of clinical trials: Observational studies |
|
|
11 |
Types of clinical trials: Experimental studies (Phase1,2,3,4 and others) |
|
|
12 |
Bioequivalence studies |
|
|
13 |
Examples |
|
|
14 |
Overview and Discussion |
|
Recommended Sources
Textbook |
- |
Additional Resources |
1. Helsinki declaration. Last version 2. ICH-GCP 3. EMA GCP regulations 4. FDA GCP regulations 5. Turkish Ministry of Health GCP regulations 6. Turkish Ministry of Health regulations about clinical trials |
Material Sharing
Documents |
- |
Assignments |
Homeworks |
Exams |
1 midterm |
Assessment
IN-TERM STUDIES |
NUMBER |
PERCENTAGE |
Midterm Exam I |
1 |
50 |
Total |
|
100 |
CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE |
1 |
50 |
CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE |
|
50 |
Total |
|
100 |
COURSE CATEGORY |
Compulsary/Elective |
Course’s Contribution to Program
No |
Program Learning Outcomes |
Contribution |
||||
1 |
2 |
3 |
4 |
5 |
||
1 |
Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting. |
|
|
X |
|
|
2 |
Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information. |
|
|
x |
|
|
3 |
Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public. |
|
|
x |
|
|
4 |
Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars. |
X |
|
|
|
|
5 |
Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice. |
|
|
|
|
x |
6 |
Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. |
|
|
|
|
X |
7 |
Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks and apply in proper manner . |
|
|
|
X |
|
8 |
Being competent to conduct and manage research and development projects, and share experimental outcomes. |
|
|
x |
|
|
9 |
Be competent to accurately and intelligibly communicate clincally relevant informaion to patients concerning prescription items and other pharmaceutical products. |
|
|
|
|
x |
10 |
Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities. |
|
|
|
|
X |
11 |
Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues. |
|
|
|
X |
|
12 |
Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students. |
|
|
|
X |
|
13 |
Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. |
|
|
|
X |
|
14 |
Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body. |
|
|
X |
|
|
ECTS
Activities |
Quantity |
Duration |
Total |
Course Duration (Including the exam week: 16x Total course hours) |
16 |
2 |
32 |
Midterm Exams |
1 |
2 |
2 |
Homework |
3 |
10 |
30 |
Final |
1 |
2 |
2 |
Total Work Load |
|
|
66 |
Total Work Load / 25 (h) |
|
|
2,64 |
ECTS Credit of the Course |
|
|
3 |