Veidlapa Nr. M-3 (8)
Study Course Description
Placement in Industrial Pharmacy
Course Code
LFK_026
Branch of Science
Basic medicine; Technology of Drug Forms
ECTS
36.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Baiba Mauriņa
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 16 Konsula Street, zftk@rsu.lv, +371 67061547
About Study Course
Objective
1. Encourage acquisition of knowledge and formation of understanding about theoretical bases and practical methods of development, manufacturing, quality evaluation of dosage forms. 2. Encourage acquisition of practical skills in preparation and quality evaluation of dosage forms.
Preliminary Knowledge
Study courses taken in the undergraduate study program Pharmacy - Inorganic, Organic, Pharmaceutical Chemistry, Quantitative Analysis, Plant and Animal Biology, Mathematics, Informatics, Physics, Physical Pharmacy, Medical Biochemistry, Environmental health, Microbiology, Medical chemistry, Pharmaceutical chemistry, Pharmacognosy, Pharmaceutical Pharmacology, Pharmaceutical technology, Practical Pharmacy and pharmaceutical legislation. Desirable knowledge in Human Anatomy, Normal Physiology, English.
Study courses completed in the Industrial Pharmacy study program: Final dosage forms, Good Manufacturing Practice, Drug registration, Pharmaceutical marketing.
Learning Outcomes
Knowledge
1.Knowledge of the production of active pharmaceutical ingredients, the development and production of finished dosage forms, the quality control process, the process of preparing and compiling the documentation required for the registration of finished dosage forms.
Skills
1.Able to use problem-solving skills for analysis of the situations encountered in pharmaceutical industry.
Competences
1.Able to participate in an interdisciplinary team, to associate themselves with the team’s objectives and to contribute to achieving common goals. Able to integrate theoretical knowledge and, if necessary, to extend their own knowledge in order to solve problems and justify their views.
Assessment
Individual work
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Title
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% from total grade
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Grade
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1.
Individual work |
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The traineeship in the amount of 36 ECTS is planned in the second and third semesters of studies in the largest pharmaceutical enterprises in Latvia - JSC Olainfarm and JSC Grindeks or in one of the EU or EEA countries, with prior agreement with the course supervisor. The amount of practice in the 2nd semester is 21 ECTS, in the 3rd semester - 15 ECTS. If necessary, the traineeship can also be implemented in the summer months between the 2nd and 3rd semesters. The traineeship in industrial pharmacy is divided into seven modules, trying to take into account the specifics of the work of an industrial pharmacist. Each module includes a theoretical part, a practical part and a defense of the module.
Timetable of the traineeship:
1. Familiarization with the company (3 weeks).
2. Quality assurance (5 weeks).
3. Development of active pharmaceutical ingredients and final dosage forms (3 weeks).
4. Production (9 weeks).
5. Marketing authorization (2 weeks).
6. Commercialization of medicines (2 weeks).
7. Pharmacovigilance (2 weeks).
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Examination
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Title
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% from total grade
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Grade
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1.
Examination |
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-
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During the traineeship, the student must prepare an traineeship report, in which he / she must describe all the points mentioned in the traineeship program, and submit it to the supervisor at the Department of Applied Pharmacy. The report shall indicate the date, the duration of working hours each day, provide an overview of the activities performed during the day, what materials you have read, what processes you have seen (according to the traineeship program). At the end of the report, the student provides an evaluation of the traineeship, a self-assessment of his / her contribution and suggestions. Report of each traineeship module is signed by the supervisor of each module - an employee of a pharmaceutical company. The evaluation of the traineeship is received after report submission and discussions about the traineeship at the Department of Applied Pharmacy.
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Study Course Theme Plan
FULL-TIME
Part 1
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Lecture
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Modality
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Location
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Contact hours
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On site
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Auditorium
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2
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Topics
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LEAN Manufacturing and Continuous Improvement (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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Lecture
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Modality
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Location
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Contact hours
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On site
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Auditorium
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2
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Topics
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Introduction to Modern Quality Concepts in Pharmaceutical Manufacturing (guest prof. V.Briedis, Lithuanian University of health sciences)
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Lecture
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Modality
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Location
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Contact hours
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On site
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Auditorium
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2
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Topics
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Regulatory Framework and Quality Standards (guest prof. V.Briedis, Lithuanian University of health sciences)
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Risk-Based Quality Management (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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Class/Seminar
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Modality
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Location
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Contact hours
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On site
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Auditorium
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4
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Topics
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Data-Driven Decision Making and Quality Metrics (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Six Sigma and Statistical Quality Control (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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4
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Topics
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LEAN Manufacturing and Continuous Improvement (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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4
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Topics
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Risk-Based Quality Management (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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4
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Topics
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Six Sigma and Statistical Quality Control (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Data-Driven Decision Making and Quality Metrics (guest prof. V.Briedis, Lithuanian University of Health Sciences)
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Total ECTS (Creditpoints):
21.00
Contact hours:
28 Academic Hours
Final Examination:
Test (Semester)
Part 2
Total ECTS (Creditpoints):
15.00
Contact hours:
0 Academic Hours
Final Examination:
Report (Placement)
Bibliography
Required Reading
1.
Prakses programma Rūpnieciskajā farmācijā
2.
Internship programme in Industrial Pharmacy (Foreign students)