COP3815 Medical Devices and Legal Law and ProcessesBahçeşehir UniversityDegree Programs CIVIL ENGINEERINGGeneral Information For StudentsDiploma SupplementErasmus Policy StatementNational QualificationsBologna Commission
CIVIL ENGINEERING
Bachelor TR-NQF-HE: Level 6 QF-EHEA: First Cycle EQF-LLL: Level 6

Ders Genel Tanıtım Bilgileri

Course Code: COP3815
Ders İsmi: Medical Devices and Legal Law and Processes
Ders Yarıyılı: Fall
Spring
Ders Kredileri:
Theoretical Practical Credit ECTS
3 0 3 6
Language of instruction: Turkish
Ders Koşulu:
Ders İş Deneyimini Gerektiriyor mu?: No
Type of course: Non-Departmental Elective
Course Level:
Bachelor TR-NQF-HE:6. Master`s Degree QF-EHEA:First Cycle EQF-LLL:6. Master`s Degree
Mode of Delivery: Face to face
Course Coordinator : Dr. Öğr. Üyesi EVİN KORKMAZ
Course Lecturer(s):
Course Assistants:

Dersin Amaç ve İçeriği

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.
Course Content:

Learning Outcomes

The students who have succeeded in this course;
Learning Outcomes
1 - Knowledge
Theoretical - Conceptual
2 - Skills
Cognitive - Practical
3 - Competences
Communication and Social Competence
Learning Competence
Field Specific Competence
Competence to Work Independently and Take Responsibility

Ders Akış Planı

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

Ders - Program Öğrenme Kazanım İlişkisi

Ders Öğrenme Kazanımları
Program Outcomes
1) Adequate knowledge in mathematics, science and civil engineering; the ability to use theoretical and practical knowledge in these areas in complex engineering problems.
2) Ability to identify, formulate, and solve complex engineering problems; ability to select and apply proper analysis and modeling methods for this purpose.
3) Ability to design a complex system, process, structural and/or structural members to meet specific requirements under realistic constraints and conditions; ability to apply modern design methods for this purpose.
4) Ability to develop, select and use modern techniques and tools necessary for the analysis and solution of complex problems encountered in civil engineering applications; ability to use civil engineering technologies effectively.
5) Ability to design, conduct experiments, collect data, analyze and interpret results for the study of complex engineering problems or civil engineering research topics.
6) Ability to work effectively within and multi-disciplinary teams; individual study skills.
7) Ability to communicate effectively in English and Turkish (if he/she is a Turkish citizen), both orally and in writing.
8) Awareness of the necessity of lifelong learning; ability to access information to follow developments in civil engineering technology.
9) To act in accordance with ethical principles, professional and ethical responsibility; having awareness of the importance of employee workplace health and safety.
10) Information about business life practices such as project management, risk management, and change management; awareness of entrepreneurship, innovation, and sustainable development.
11) Knowledge about contemporary issues and the global and societal effects of engineering practices on health, environment, and safety; awareness of the legal consequences of civil engineering solutions.

Ders - Öğrenme Kazanımı İlişkisi

No Effect 1 Lowest 2 Low 3 Average 4 High 5 Highest
           
Program Outcomes Level of Contribution
1) Adequate knowledge in mathematics, science and civil engineering; the ability to use theoretical and practical knowledge in these areas in complex engineering problems.
2) Ability to identify, formulate, and solve complex engineering problems; ability to select and apply proper analysis and modeling methods for this purpose.
3) Ability to design a complex system, process, structural and/or structural members to meet specific requirements under realistic constraints and conditions; ability to apply modern design methods for this purpose.
4) Ability to develop, select and use modern techniques and tools necessary for the analysis and solution of complex problems encountered in civil engineering applications; ability to use civil engineering technologies effectively.
5) Ability to design, conduct experiments, collect data, analyze and interpret results for the study of complex engineering problems or civil engineering research topics.
6) Ability to work effectively within and multi-disciplinary teams; individual study skills.
7) Ability to communicate effectively in English and Turkish (if he/she is a Turkish citizen), both orally and in writing.
8) Awareness of the necessity of lifelong learning; ability to access information to follow developments in civil engineering technology.
9) To act in accordance with ethical principles, professional and ethical responsibility; having awareness of the importance of employee workplace health and safety.
10) Information about business life practices such as project management, risk management, and change management; awareness of entrepreneurship, innovation, and sustainable development.
11) Knowledge about contemporary issues and the global and societal effects of engineering practices on health, environment, and safety; awareness of the legal consequences of civil engineering solutions.

Öğrenme Etkinliği ve Öğretme Yöntemleri

Ölçme ve Değerlendirme Yöntemleri ve Kriterleri

Assessment & Grading

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

İş Yükü ve AKTS Kredisi Hesaplaması

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