COP3815 Medical Devices and Legal Law and ProcessesBahçeşehir UniversityDegree Programs SPEECH AND LANGUAGE THERAPYGeneral Information For StudentsDiploma SupplementErasmus Policy StatementNational QualificationsBologna Commission
SPEECH AND LANGUAGE THERAPY
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) To use theoretic and methodological approach, evidence-based principles and scientific literature in Speech and Language Therapy field systematically for practice.
2) To have theoretic and practical knowledge for individual's, family's and the community's health promotion and protection.
3) To use information and health technologies in practice and research in the field of Speech and Language Therapy.
4) To communicate effectively with advisee, colleagues for effective professional relationships.
5) To be able to monitor occupational information using at least one foreign language, to collaborate and communicate with colleagues at international level.
6) To use life-long learning, problem-solving and critical thinking skills.
7) To act in accordance with ethical principles and values in professional practice.
8) To take part in research, projects and activities within sense of social responsibility and interdisciplinary approach.
9) To be able to search for literature in health sciences databases and information sources to access to information and use the information effectively.
10) To take responsibility and participate in the processes actively for training of other therapist, education of health professionals and individuals about speech and languege therapy.
11) To carry out speech and languge therapy practices considering cultural differences and different health needs of different groups in the community.