Pharmaceutical Industry with BAYER (PIWB)

Course Code:

PHAR 578

Course Type:

Elective

P:

2

Lab:

0

Credits:

2

ECTS:

3

Course Language:

Turkish

English

Course Coordinator:

Hande SİPAHİ

Courses given by:

Hande SİPAHİ

Course Objectives:

Developed in partnership with Bayer, the PIWB programme is designed for pharmacy students who aim to work in the pharmaceutical industry. The primary goal of pharmaceutical industry program is to expose pharmacy students to the role of pharmacists within the pharmaceutical industry. To provide an introduction to the pharmaceutical industry, the drug development process, and regulatory requirements governing the pharmaceutical industry.

Course Content:

This programme covers the industrial pharmacist role from formulation through to QA and QC, and also regulatory affairs and lean processes. Identify the key stages in the lifecycle of pharmaceutical products as well as activities that occur in each stage in a pharmaceutical company, including: discovery of a new molecule, nonclinical and clinical trials, manufacturing and formulation development, regulatory approval and on-market support.

Course Methodology:

1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5: Simulation, 6: Video, 7: Applications, 8: Case Study

Course Evaluation Methods:

A: Written exam, B: multiple choses, C: Filling the blank, D: False and troth, E: Oral Exam F: Portfolio, G: Contribution of course activities, H: Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes	Programme learning outcomes	Teaching Methods	Assessment Methods
1) Understand the basic terminology used in the pharmaceutical industry as well as key regulatory principles and processes governing the stages in the development of a pharmaceutical product.	1,2,3,4,5,7,9	1,2,3,4,5,6,7,8	F, G
2) Identify the key stages in the lifecycle of pharmaceutical products as well as activities that occur in each stage, including: discovery of a new molecule nonclinical and clinical trials manufacturing and formulation development regulatory approval on-market support	1,2,3,4,5,7,9	1,2,3,4,5,6,7,8	F, G
3) Describe the general regulatory requirements relating to good manufacturing practice and marketing.	1,2,3,4,5,7,9	1,2,3,4,5,6,7,8	F, G
4) Explain who and what is involved in each product lifecycle stage	1,2,3,4,5,7,9	1,2,3,4,5,6,7,8	F, G
5) Briefly outline the critical events and their impact for each product lifecycle stage for drugs, biologics and medical devices.	1,2,3,4,5,7,9	1,2,3,4,5,6,7,8	F, G

Course Flow

COURSE CONTENT
Week	Teorical Topics	Study Materials
1	Introduction of the Pharmaceutical Industry/Organization	Syllabus
2	Pharmacovigilance & Medical Information	Notes of the guest lecturers
3	Clinical Trials	Notes of the guest lecturers
4	Medical Affairs Studies	Notes of the guest lecturers
5	Medical Affairs	Notes of the guest lecturers
6	Medical Governance & Code Compliance	Notes of the guest lecturers
7	Regulatory Affairs	Notes of the guest lecturers
8	Quality Assurance	Notes of the guest lecturers
9	Sales & Marketing	Notes of the guest lecturers
10	Market Access	Notes of the guest lecturers
11	Business Support	Notes of the guest lecturers
12	Legal	Notes of the guest lecturers
13	Corporate Communications	Notes of the guest lecturers
14	Human Resources	Notes of the guest lecturers

Recommended Sources

RECOMMENDED SOURCES
Textbook	Notes of the guest lecturers
Additional Resources

Material Sharing

MATERIAL SHARING
Documents	Notes of the guest lecturers
Exams	Attendance and participation

Assessment

ASSESSMENT
IN-TERM STUDIES	NUMBER	PERCENTAGE
Midterm Exam I	Antendense	30
Contrabution of course activities	Participation	70
Total		100
CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE
CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE		100
Total		100

COURSE CATEGORY

Selective

Course’s Contribution to Program

COURSE'S CONTRIBUTION TO PROGRAM
No	Program Learning Outcomes	Contribution
No	Program Learning Outcomes	1	2	3	4	5
1	Has national and international up-to-date, theoretical and applied knowledge in the field of pharmacy.					X
2	Defines problems related to the profession, collects data, evaluates its accuracy and reliability, develops evidence-based solutions, shares them with healthcare professionals, makes necessary explanations to other people.					X
3	Communicates accurately and effectively in accordance with cultural and ethical values with all relevant professional groups, especially those working in the field of health, and all segments of society, using information and communication technologies.					X
4	Takes into account the law and ethics when dealing with public health issues.					X
5	Acts as a pharmacist with high career awareness, self-confidence, leadership spirit, who is prone to teamwork, entrepreneurial, productive and able to manage financial resources.					X
6	Based on the principle of pharmaceutical care, Acts as an easily accessible health consultant with a patient-oriented approach and plays an active role in constantly informing the society.
7	Improves his/her knowledge by participating in in-service training and activities in line with the needs of the century and society, takes part in the professional development of colleagues and adopts the lifelong learning principle.					X
8	Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results.
9	Applies knowledge and skills for the benefits of the society taking part in social responsibility projects.					X
10	Fulfills the requirements of quality management systems using the theoretical and applied knowledge acquired in the field.

ECTS

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
Activities	Quantity	Duration (Hour)	Total Workload (Hour)
Course Duration	14	2	28
Hours for off-the-classroom study (Pre-study, practice)	14	2,5	35
Total Work Load			63
Total Work Load / 25 (h)			2,5
ECTS Credit of the Course			3

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