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Course Code: 
PHAR 563
Course Type: 
Elective
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
Turkish
English
Course Objectives: 
Tha aim of the course is to educate students (medicine, pharmacy and nursery) about rules, types and metodology of clinical researches as an investigator, sponsor, monitor or decision maker.
Course Content: 

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.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

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
(Hour)

Total
Workload
(Hour)

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