LAW
Bachelor	TR-NQF-HE: Level 6	QF-EHEA: First Cycle	EQF-LLL: Level 6

Course Introduction and Application Information

Course Code	Course Name	Semester	Theoretical	Practical	Credit	ECTS
COP3815	Medical Devices and Legal Law and Processes	Spring	3	0	3	6

This catalog is for information purposes. Course status is determined by the relevant department at the beginning of semester.

Basic information

Language of instruction:	Turkish
Type of course:	Non-Departmental Elective
Course Level:	Bachelor’s Degree (First Cycle)
Mode of Delivery:	Face to face
Course Coordinator :	Dr. Öğr. Üyesi EVİN KORKMAZ
Course Objectives:	Aims to give information to students about pharmaceuticals and medical devices, patient care-oriented products that affects the patient's quality of life in areas such as Oncology and Nephrology, national and international companies producing all of them, the dynamics of the market in Turkey, on the management of relationships with all internal and external customers.

Learning Outcomes

The students who have succeeded in this course;
1) Getting an idea of the fundamentals and priorities in pharma and medical device
2) Knowing products that are focused on patient's quality of life and patient care in fields such as Oncology and Nephrology
3) Getting an idea of roles and the impotance of collaboration between various functions & departments
4) Understanding the scope of common initiatives between the industry and Ministry of Health/Social Security Institution and the importance of regulations
5) Getting insight of collaborative projects & relationship management with key opinion leaders/associations
6) Understanding the competencies to work in various roles of the industry
7) Increasing the ability to look from different perspectives, thinking multidisciplinary and finding strategic solutions

Course Content

Weekly Detailed Course Contents

Week	Subject	Related Preparation
1)	Introduction of the course
2)	Innovation of a new drug or medical device, research and development Introduction and development processes of products focused on the patient's quality of life and patient care in areas such as Oncology and Nephrology. How does it affect the researches such as nutrition in the oncology and nephrology patients, continuity of daily life?
3)	Leading the world of medicine, medical products and devices and managing the ideas leaders
4)	Marketing and brand management in the field of medicine, medical products and devices
5)	The importance of health policy and economics on access to the treatment
6)	Building and managing high performing sales teams
7)	"Medical device purchase criteria Life span of medical devices Impact of operating costs on device purchase decision "
8)	Mid-term
9)	The importance of logistics and customer operations in successful product management. How does the logistics process work in the treatment access and what is the importance ?
10)	Why 'Quality is the Key' in medical device and pharmaceutical industry ? Why Drug and Medical Device products are regulated ? What is the local and global regulation frame ?
11)	Financial planning and analysis and key metrics on financial decision making
12)	Ability to acquire skills in a leading company in the industry, ability to retain talent and in-house personal development programs
13)	Rules of successful management of a company in a challenging environment (Interview with the General Manager)
14)	Evaluation of the Course

Sources

Course Notes / Textbooks:

References:

http://istanbultip.istanbul.edu.tr/wp-content/uploads/2015/02/6.I%CC%87lac%CC%A7-endu%CC%88strisinde-Ar-GE.pdf https://www.ey.com/Publication/vwLUAssets/EY-the-changing-role-of-the-cfo/$FILE/EY-the-changing-role-of-the-cfo.pdf http://www.jasstudies.com/Makaleler/925445489_9-Yrd.%20Doç.%20Dr.%20Erkan%20Tabancalı%20-%20Arş.%20Gör.%20Mithat%20KORUMAZ.pdf https://www.slideshare.net/HakanSelahi/yetenek-ynetm http://www.resmigazete.gov.tr/eskiler/2015/07/20150703-2.htm http://www.edchreturkey-eu.coe.int/Source/Resources/Trainingset/Module13_Team_Building_tr.pdf https://www.titck.saglik.gov.tr/PortalAdmin/Uploads/UnitPageAttachment/K1ckbWKP.pdf

Evaluation System

Semester Requirements	Number of Activities	Level of Contribution
Midterms	1	% 50
Final	1	% 50
Total		% 100
PERCENTAGE OF SEMESTER WORK		% 50
PERCENTAGE OF FINAL WORK		% 50
Total		% 100

ECTS / Workload Table

Activities	Number of Activities	Duration (Hours)	Workload
Course Hours	3	13	39
Study Hours Out of Class	14	7	98
Midterms	1	2	2
Final	1	2	2
Total Workload			141

Contribution of Learning Outcomes to Programme Outcomes

No Effect	1 Lowest	2 Low	3 Average	4 High	5 Highest

	Program Outcomes	Level of Contribution
1)	List the relations between concepts and institutions related to various legal disciplines and this concepts and institutions.
2)	Have the knowledge of legal methodology and methods of comment.
3)	Comment the modern legal gains with the historical knowledge.
4)	Have the knowledge of philosophical currents of thought which are the bases of legal rules.
5)	Have the knowledge of legal regulations, judicial decisions and the scientific evaluations related to them.
6)	Resolve the juridical disagreements in light of legal acts, juridical decisions and doctrine.
7)	Use at least one foreign language as scientific language.
8)	Have the knowledge of the political and juridical foundation of the state.
9)	Have the knowledge of the historical development of the rights of individuals and societies and of the basic documents which are accepted throughout this development.
10)	Have the ability to resolve the disagreements which can violate the social order in national or international level.
11)	Have the ability to prevent the juridical disagreements between individuals.
12)	Have the knowledge of international and comparative law systems.
13)	Have the knowledge of the construction and the conduct of the national and international commercial relations.
14)	Use Turkish in an efficient way both verbal and written.
15)	Have the professional and ethical responsibility.
16)	Have the knowledge on the European Union’s legislation and institutions.
17)	Have the knowledge on juridical regulations and applications related to economical and financial mechanisms.
18)	Have the knowledge of the operation of the national and the international judicial bodies.