Veidlapa Nr. M-3 (8)
Study Course Description
Practical Pharmacy and Pharmaceutical Legislation
Course Code
LFK_029
Branch of Science
Basic medicine; Social Pharmacy
ECTS
8.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Nora Krauja
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 16 Dzirciema Street, zftk@rsu.lv, +371 67061547
About Study Course
Objective
1. To get acquainted with the duties and tasks of a pharmacist regulated in the pharmaceutical legislation of Latvia and the European Union, in pharmaceutical companies (FDU) and their supervision authorities; the organisation of company activities, the tax system, the basics of company financing, the basic principles of accounting and economic activity analysis at FDU.
2. To acquire theoretical knowledge of the main legislative enactments in the pharmaceutical industry.
3. To develop skills in the practical application of regulatory acts in the operation of companies.
Preliminary Knowledge
Pharmaceutical chemistry, pharmacognosy, pharmaceutical and industrial dosage form technology, pharmacology, economics, information technology.
Learning Outcomes
Knowledge
1.As a result of completing the study course, students will be able to explain the functions of a pharmacist in pharmaceutical companies and their supervision authorities, in accordance with the legislative requirements of Latvia and the European Union, as well as be able to evaluate the results of the company’s economic activity.
Skills
1.As a result of completing the study course, students will be able to apply legislative enactments, fulfilling the duties of a pharmacist in pharmaceutical companies and organise the documentation of economic activity in pharmacies.
Competences
1.Will be able to organise the day-to-day operational activities of pharmaceutical companies, in accordance with legislative requirements, assess discrepancies in the actual daily work processes.
Assessment
Individual work
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Title
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% from total grade
|
Grade
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|---|---|---|
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1.
Individual work |
-
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-
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Work with relevant literature, practical work with searching and collecting information, preparing a presentation on a specific topic.
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Examination
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Title
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% from total grade
|
Grade
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|---|---|---|
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1.
Examination |
-
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-
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Independent and practical assignments, presentation, oral exam. The overall assessment of the course will consist of the semester test and exam grades. Exam – final examination at the end of the study course to obtain an assessment for the learning outcomes achieved. Exam results will be assessed on a 10-point scale. The assessment consists of the cumulative assessment of the grades obtained during the semester for the colloquia (50%) and the performance of the tasks of the final examination (50%).
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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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|---|---|---|
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On site
|
Auditorium
|
2
|
Topics
|
Pharmaceutical Law, terminology. Procedures for opening and operating pharmacies. Licensing terms. Regulations for storing medicinal products in pharmacies. Classification of medicinal products as prescription and non-prescription medicinal products. Regulations for pricing medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmaceutical Law, terminology. Procedures for opening and operating pharmacies. Licensing terms. Regulations for storing medicinal products in pharmacies. Classification of medicinal products as prescription and non-prescription medicinal products. Regulations for pricing medicinal products.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmaceutical Law, terminology. Procedures for opening and operating pharmacies. Licensing terms. Regulations for storing medicinal products in pharmacies. Classification of medicinal products as prescription and non-prescription medicinal products. Regulations for pricing medicinal products.
|
-
Lecture
|
Modality
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Location
|
Contact hours
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|---|---|---|
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On site
|
Auditorium
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2
|
Topics
|
Regulations on the distribution of prescription medicinal products. Procedure for distribution of narcotic and psychotropic drugs. Treatment courses. Prescription expiration dates and storage time in the pharmacy.
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-
Class/Seminar
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Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Regulations on the distribution of prescription medicinal products. Procedure for distribution of narcotic and psychotropic drugs. Treatment courses. Prescription expiration dates and storage time in the pharmacy.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
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2
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Topics
|
Regulations on the distribution of prescription medicinal products. Procedure for distribution of narcotic and psychotropic drugs. Treatment courses. Prescription expiration dates and storage time in the pharmacy.
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-
Lecture
|
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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Procedure of the reimbursement for the acquisition of medicinal products. Medicinal product wholesalers. Good distribution practice of medicinal products.
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-
Class/Seminar
|
Modality
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Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
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Topics
|
Procedure of the reimbursement for the acquisition of medicinal products. Medicinal product wholesalers. Good distribution practice of medicinal products.
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-
Lecture
|
Modality
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Location
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Contact hours
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|---|---|---|
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On site
|
Auditorium
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2
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Topics
|
Preparation of medicinal products in the pharmacy, control of prepared medicinal products. Regulations on labelling of medicinal products. Distribution of industrially produced medicinal products in a pharmacy. Procedure for the circulation of alcohol.
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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
|
Auditorium
|
2
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Topics
|
Preparation of medicinal products in the pharmacy, control of prepared medicinal products. Regulations on labelling of medicinal products. Distribution of industrially produced medicinal products in a pharmacy. Procedure for the circulation of alcohol.
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-
Class/Seminar
|
Modality
|
Location
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Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Preparation of medicinal products in the pharmacy, control of prepared medicinal products. Regulations on labelling of medicinal products. Distribution of industrially produced medicinal products in a pharmacy. Procedure for the circulation of alcohol.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Preparation of medicinal products in the pharmacy, control of prepared medicinal products. Regulations on labelling of medicinal products. Distribution of industrially produced medicinal products in a pharmacy. Procedure for the circulation of alcohol.
|
-
Lecture
|
Modality
|
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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Procedure of the distribution and quality control of medicinal products. Requirements for import and export of medicinal products. Health Inspectorate, State Agency of Medicines, functions and rights thereof.
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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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Other
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2
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Topics
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Procedure of the distribution and quality control of medicinal products. Requirements for import and export of medicinal products. Health Inspectorate, State Agency of Medicines, functions and rights thereof.
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-
Lecture
|
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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Pharmaceutical manufacturing companies, structure and functions thereof. Qualification requirements for personnel. Procedure for opening and licensing a pharmaceutical manufacturing company. Medicinal product quality assurance system in manufacturing companies.
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-
Lecture
|
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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Occupational protection in a company. Establishment of the organisational structure of occupational protection.
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Total ECTS (Creditpoints):
5.00
Contact hours:
50 Academic Hours
Final Examination:
Test (Semester)
Part 2
-
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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Management of pharmaceutical companies. Responsibilities and functions of a pharmacy manager. Company management methods. Qualification requirements for pharmaceutical personnel.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Management of pharmaceutical companies. Responsibilities and functions of a pharmacy manager. Company management methods. Qualification requirements for pharmaceutical personnel.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Management of pharmaceutical companies. Responsibilities and functions of a pharmacy manager. Company management methods. Qualification requirements for pharmaceutical personnel.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Management of pharmaceutical companies. Responsibilities and functions of a pharmacy manager. Company management methods. Qualification requirements for pharmaceutical personnel.
|
-
Class/Seminar
|
Modality
|
Location
|
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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Record-keeping as a method of information collection and work organisation in companies and administrative institutions. Documents, classification thereof. Document handling. Archive. Personnel documents.
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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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International organisations whose activities affect the field of pharmacy. The European Union, its institutions, legal system, decision-making, budget and structural measures.
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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
|
Auditorium
|
2
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Topics
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The role of government in the market economy. Characterisation of the pharmacy market. Business objectives, basic principles, process elements. Starting a business and the process of company functioning. Possibilities of commercialisation of innovative ideas.
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-
Class/Seminar
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Modality
|
Location
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Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
The role of government in the market economy. Characterisation of the pharmacy market. Business objectives, basic principles, process elements. Starting a business and the process of company functioning. Possibilities of commercialisation of innovative ideas.
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-
Lecture
|
Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
National fiscal and tax policy, impact thereof on other governmental policies. State taxes applicable in the Republic of Latvia. Detailed description of individual taxes, elements thereof, administration and use for purposes.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
National fiscal and tax policy, impact thereof on other governmental policies. State taxes applicable in the Republic of Latvia. Detailed description of individual taxes, elements thereof, administration and use for purposes.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
National fiscal and tax policy, impact thereof on other governmental policies. State taxes applicable in the Republic of Latvia. Detailed description of individual taxes, elements thereof, administration and use for purposes.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Financial accounting in the company, tasks, basic principles and types thereof, as well as groups of accounting objects. Accounting and organisation thereof. Accounting documents, groups thereof, requirements for documents. Bookkeeping accounts.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Financial accounting in the company, tasks, basic principles and types thereof, as well as groups of accounting objects. Accounting and organisation thereof. Accounting documents, groups thereof, requirements for documents. Bookkeeping accounts.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Annual statement, objectives, stages and deadlines for the preparation thereof. Inventory procedure. Structure of the annual statement: financial statement and management report. Financial statement documents, characteristics, principles of preparation thereof.
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-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Annual statement, objectives, stages and deadlines for the preparation thereof. Inventory procedure. Structure of the annual statement: financial statement and management report. Financial statement documents, characteristics, principles of preparation thereof.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Annual statement, objectives, stages and deadlines for the preparation thereof. Inventory procedure. Structure of the annual statement: financial statement and management report. Financial statement documents, characteristics, principles of preparation thereof.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Financial analysis, objectives and tasks thereof. Internal and external financial analysis. Methods of financial analysis. Financial planning and demand forecasting.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Financial analysis, objectives and tasks thereof. Internal and external financial analysis. Methods of financial analysis. Financial planning and demand forecasting.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Determination of costs and revenue. Classification of costs, alternative costs. Cost and price calculation in the company’s activities. Company financing, types and sources thereof. Financing with equity and borrowed capital.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Determination of costs and revenue. Classification of costs, alternative costs. Cost and price calculation in the company’s activities. Company financing, types and sources thereof. Financing with equity and borrowed capital.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Determination of costs and revenue. Classification of costs, alternative costs. Cost and price calculation in the company’s activities. Company financing, types and sources thereof. Financing with equity and borrowed capital.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Investments, characteristics thereof and evaluation of economic efficiency. Business plan of a company. Fundamentals of marketing. Identification of consumer needs and product promotion measures. Fundamentals of project management.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Investments, characteristics thereof and evaluation of economic efficiency. Business plan of a company. Fundamentals of marketing. Identification of consumer needs and product promotion measures. Fundamentals of project management.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmacoeconomic evaluation, possibilities for the application thereof. Analytical methods used in pharmacoeconomic evaluation, characterisation thereof.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmacoeconomic evaluation, possibilities for the application thereof. Analytical methods used in pharmacoeconomic evaluation, characterisation thereof.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Oral)
Bibliography
Required Reading
1.
Farmācijas likums. Pieejams no: https://likumi.lv/doc.php?id=43127
2.
Likums "Par narkotisko un psihotropo vielu un zāļu likumīgās aprites kārtību". Pieejams no: https://likumi.lv/doc.php?id=40283
3.
Likums "Par prekursoriem". Pieejams no: https://likumi.lv/doc.php?id=40284
4.
Ministru kabineta 2006.gada 18.aprīļa noteikumi Nr.304 «Noteikumi par zāļu ražošanas un kontroles kārtību, par zāļu ražošanu atbildīgās amatpersonas kvalifikācijas prasībām un profesionālo pieredzi un kārtību, kādā zāļu ražošanas uzņēmumam izsniedz l
5.
Ministru kabineta 2006.gada 9.maija noteikumi Nr.376 «Zāļu reģistrēšanas kārtība»
6.
Ministru kabineta 2005.gada 22.novembra noteikumi Nr.885 «Zāļu klasifikācijas kārtība»
7.
Ministru kabineta 2006.gada 17.janvāra noteikumi Nr.57 «Noteikumi par zāļu marķēšanas kārtību un zāļu lietošanas instrukcijai izvirzāmajām prasībām»
8.
Ministru kabineta 2013.gada 22.janvāra noteikumi Nr.47 «Farmakovigilances kārtība»
9.
Ministru kabineta 2007.gada 26.jūnija noteikumi Nr.416 «Zāļu izplatīšanas un kvalitātes kontroles kārtība»
10.
Ministru kabineta 2007.gada 26.jūnija noteikumi Nr.436 «Zāļu ievešanas un izvešanas kārtība»
11.
Ministru kabineta 2005.gada 25.oktobra noteikumi Nr.803 «Noteikumi par zāļu cenu veidošanas principiem»
12.
Ministru kabineta 2006.gada 31.oktobra noteikumi Nr.899 «Ambulatorajai ārstēšanai paredzēto zāļu un medicīnisko ierīču iegādes izdevumu kompensācijas kārtība»
13.
Ministru kabineta 2011.gada 17.maija noteikumi Nr.378 «Zāļu reklamēšanas kārtība un kārtība, kādā zāļu ražotājs ir tiesīgs nodot ārstiem bezmaksas zāļu paraugus»
14.
Ministru kabineta 2008.gada 17.jūnija noteikumi Nr.441 «Narkotisko un psihotropo vielu un zāļu iepirkšanas, saņemšanas, uzglabāšanas, izplatīšanas, izsniegšanas, uzskaites un iznīcināšanas kārtība zāļu un veterināro zāļu ražošanā, zāļu un veterināro
15.
Ministru kabineta 2007.gada 27.marta noteikumi Nr.220 «Zāļu iegādes, uzglabāšanas, izlietošanas, uzskaites un iznīcināšanas kārtība ārstniecības iestādēs un sociālās aprūpes institūcijās»
16.
Ministru kabineta 2011.gada 19.oktobra noteikumi Nr.800 «Farmaceitiskās darbības licencēšanas kārtība»
17.
Ministru kabineta 2010.gada 23.marta noteikumi Nr.288 «Aptieku darbības noteikumi»
18.
Ministru kabineta 2011.gada 2.augusta noteikumi Nr.610 «Aptieku un aptieku filiāļu izvietojuma kritēriji»
19.
Ministru kabineta 2004.gada 27.aprīļa noteikumi Nr.454 «Farmaceitu un farmaceitu asistentu reģistrēšanas kārtība»
20.
Ministru kabineta 2010.gada 23.marta noteikumi Nr.290 «Farmaceitu profesionālās kvalifikācijas sertifikātu izsniegšanas, pārreģistrēšanas un anulēšanas kārtība»
21.
Ministru kabineta 2005.gada 8.marta noteikumi Nr.175 «Recepšu veidlapu izgatavošanas un uzglabāšanas, kā arī recepšu izrakstīšanas un uzglabāšanas noteikumi»
22.
ES likumdošana
23.
Latvijas Republikas likums ”Likums par budžetu un finanšu vadību”
24.
Latvijas Republikas likums ”Par nodokļiem un nodevām”
25.
Latvijas Republikas likums ”Par iedzīvotāju ienākuma nodokli”
26.
Latvijas Republikas likums ”Par uzņēmumu ienākuma nodokli”
27.
Latvijas Republikas likums ”Mikrouzņēmumu nodokļa likums”
28.
Latvijas Republikas likums ”Pievienotās vērtības nodokļa likums”
29.
Latvijas Republikas likums ”Par valsts sociālo apdrošināšanu”
30.
Latvijas Republikas likums ”Par maternitātes un slimības apdrošināšanu”
31.
Latvijas Republikas likums ”Valsts sociālo pabalstu likums”
32.
Ministru kabineta 05.01.2016. noteikumi Nr.1 ”Noteikumi par neapliekamā minimuma un nodokļa atvieglojuma apmēru iedzīvotāju ienākuma nodokļa aprēķināšanai”
33.
Ministru kabineta 08.04.1997. noteikumi Nr.138 ”Noteikumi par iedzīvotāju ienākuma nodokļa papildu atvieglojumiem invalīdiem, politiski represētajām personām un nacionālās pretošanās kustības dalībniekiem”
34.
Ministru kabineta 15.01.2013. noteikumi Nr.40 ”Noteikumi par pievienotās vērtības nodokļa deklarācijām”
35.
Ministru kabineta 22.12.2009. noteikumi Nr.1546 ”Noteikumi par bērna piedzimšanas pabalsta piešķiršanas un izmaksāšanas kārtību”
36.
Ministru kabineta 22.12.2009. noteikumi Nr.1609 ”Noteikumi par bērna kopšanas pabalsta un piemaksas pie bērna kopšanas pabalsta un vecāku pabalsta par dvīņiem vai vairākiem vienās dzemdībās dzimušiem bērniem apmēru, tā pārskatīšanas kārtību un pabals
37.
Latvijas Republikas likums ”Komerclikums”
38.
Latvijas Administratīvo pārkāpumu kodekss
39.
Latvijas Republikas likums ”Par grāmatvedību”
40.
Ministru kabineta 2003.gada 21.oktobra noteikumi Nr.585 ”Noteikumi par grāmatvedības kārtošanu un organizāciju”
41.
Ministru kabineta 2003.gada 21.oktobra noteikumi Nr.584 ”Kases operāciju uzskaites noteikumi”
42.
Latvijas Republikas likums ”Gada pārskatu un konsolidēto gada pārskatu likums”
43.
Ārvalstu studentiem/For international students
44.
Pharmaceutical Law
45.
Body of European Union legislation
46.
Commercial Law
Additional Reading
1.
Ministru kabineta 2010.gada 23.martā noteikumi Nr.289 «Noteikumi par zāļu klīniskās izpētes un lietošanas novērojumu veikšanas kārtību, pētāmo zāļu marķēšanu un kārtību, kādā tiek vērtēta zāļu klīniskās izpētes atbilstība labas klīniskās prakses pras