COP3815 Medical Devices and Legal Law and ProcessesBahçeşehir UniversityDegree Programs MOLECULAR BIOLOGY AND GENETICSGeneral Information For StudentsDiploma SupplementErasmus Policy StatementNational QualificationsBologna Commission
MOLECULAR BIOLOGY AND GENETICS
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) Utilize the wealth of information stored in computer databases to answer basic biological questions and solve problems such as diagnosis and treatment of diseases. 3
2) Acquire an ability to compile and analyze biological information, clearly present and discuss the conclusions, the inferred knowledge and the arguments behind them both in oral and written format. 4
3) Develop critical, creative and analytical thinking skills. 5
4) Develop effective communication skills and have competence in scientific speaking, reading and writing abilities in English and Turkish. 3
5) Gain knowledge of different techniques and methods used in genetics and acquire the relevant laboratory skills. 4
6) Detect biological problems, learn to make hypothesis and solve the hypothesis by using variety of experimental and observational methods. 4
7) Gain knowledge of methods for collecting quantitative and qualitative data and obtain the related skills. 3
8) Conduct research through paying attention to ethics, human values and rights. Pay special attention to confidentiality of information while working with human subjects. 5
9) Obtain basic concepts used in theory and practices of molecular biology and genetics and establish associations between them. 4
10) Search and use literature to improve himself/herself and follow recent developments in science and technology. 5
11) Be aware of the national and international problems in the field and search for solutions. 4