COP3815 Medical Devices and Legal Law and ProcessesBahçeşehir UniversityDegree Programs ENERGY SYSTEMS ENGINEERINGGeneral Information For StudentsDiploma SupplementErasmus Policy StatementNational QualificationsBologna Commission
ENERGY SYSTEMS ENGINEERING
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 Fall 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) Build up a body of knowledge in mathematics, science and Energy Systems Engineering subjects; use theoretical and applied information in these areas to model and solve complex engineering problems.
2) Ability to identify, formulate, and solve complex Energy Systems Engineering problems; select and apply proper modeling and analysis methods for this purpose.
3) Ability to design complex Energy systems, processes, devices or products under realistic constraints and conditions, in such a way as to meet the desired result; apply modern design methods for this purpose.
4) Ability to devise, select, and use modern techniques and tools needed for solving complex problems in Energy Systems Engineering practice; employ information technologies effectively.
5) Ability to design and conduct numerical or pysical experiments, collect data, analyze and interpret results for investigating the complex problems specific to Energy Systems Engineering.
6) Ability to cooperate efficiently in intra-disciplinary and multi-disciplinary teams; and show self-reliance when working on Energy Systems-related problems
7) Ability to communicate effectively in English and Turkish (if he/she is a Turkish citizen), both orally and in writing. Write and understand reports, prepare design and production reports, deliver effective presentations, give and receive clear and understandable instructions.
8) Recognize the need for life-long learning; show ability to access information, to follow developments in science and technology, and to continuously educate oneself.
9) Develop an awareness of professional and ethical responsibility, and behave accordingly. Be informed about the standards used in Energy Systems Engineering applications.
10) Learn about business life practices such as project management, risk management, and change management; develop an awareness of entrepreneurship, innovation, and sustainable development.
11) Acquire knowledge about the effects of practices of Energys Systems Engineering on health, environment, security in universal and social scope, and the contemporary problems of Energys Systems engineering; is aware of the legal consequences of Energys Systems engineering solutions.