Veidlapa Nr. M-3 (8)
Study Course Description
Introduction to the Registration of Medicinal Products
Course Code
LFK_036
Branch of Science
Basic medicine; Social Pharmacy
ECTS
3.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time; Part-Time
Study Course Implementer
Course Supervisor
Milana Špoģe
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 promote the acquisition of knowledge and formation of understanding of dosage form development, manufacturing of medicinal products, manufacturing process validation, dosage form quality assessment.
2. To promote the acquisition of practical skills for the preparation of documentation for the registration of medicinal products.
Preliminary Knowledge
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology. Knowledge of human anatomy, normal physiology and English is desirable.
Learning Outcomes
Knowledge
1.After successful fulfilment of the requirements of the study course students will have mastered knowledge, which will allow: 1. To understand the importance of the dosage form development process. 2. To understand the nature and importance of the medicinal product registration process.
Skills
1.As a result of mastering the study course, students: 1. Will be able to apply knowledge on the preparation of documents for the registration of medicinal products. 2. Will be able to assess the compliance of medicinal product registration documents with the requirements of the European Pharmacopoeia and the guidelines on the quality of medicinal products. 3. Will be able to present the results of one’s practical work correctly.
Competences
1.As a result of completing the study course, students will be able to appreciate the importance of the rules for the registration of medicinal products in the preparation of registration documents.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Individual work – solving situations according to the topics of the study course.
In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
Examination:
• solving situations independently during practical classes;
• final examination – solving situations at the end of the semester.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Registration of medicinal products. The history of registration of medicinal products in Latvia.
State Agency of Medicines.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Laws and regulations governing the registration of medicinal products.
Regulations of the Cabinet of Ministers of the Republic of Latvia on registration of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Laws and regulations governing the registration of medicinal products.
Regulations of the Cabinet of Ministers of the Republic of Latvia on registration of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of finished dosage forms. Basic principles of dosage form development.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Use of the regulations on registration of medicinal products and other laws and regulations governing the registration of medicinal products during dosage form development, manufacturing, quality assessment and stability studies.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Use of the regulations on registration of medicinal products and other laws and regulations governing the registration of medicinal products during dosage form development, manufacturing, quality assessment and stability studies.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Development of the European Pharmacopoeia. European Pharmacopoeia Commission.
Working and expert groups of the European Pharmacopoeia Commission and their activities.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
National registration. Central registration. Registration of medicinal products according to the requirements of SAP and DCP.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of the registration documentation. Components of quality documentation and characteristics thereof.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of the registration documentation. Components of quality documentation and characteristics thereof.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Regulations on the labelling of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Regulations on the preparation of the Summary of Product Characteristics and the Instructions for Use.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Manufacturers of medicinal products in Latvia. Qualified person at a medicinal product manufacturing site.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
PART-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Registration of medicinal products. The history of registration of medicinal products in Latvia.
State Agency of Medicines.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Laws and regulations governing the registration of medicinal products.
Regulations of the Cabinet of Ministers of the Republic of Latvia on registration of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Laws and regulations governing the registration of medicinal products.
Regulations of the Cabinet of Ministers of the Republic of Latvia on registration of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of finished dosage forms. Basic principles of dosage form development.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Use of the regulations on registration of medicinal products and other laws and regulations governing the registration of medicinal products during dosage form development, manufacturing, quality assessment and stability studies.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Use of the regulations on registration of medicinal products and other laws and regulations governing the registration of medicinal products during dosage form development, manufacturing, quality assessment and stability studies.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Development of the European Pharmacopoeia. European Pharmacopoeia Commission.
Working and expert groups of the European Pharmacopoeia Commission and their activities.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
National registration. Central registration. Registration of medicinal products according to the requirements of SAP and DCP.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of the registration documentation. Components of quality documentation and characteristics thereof.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Characteristics of the registration documentation. Components of quality documentation and characteristics thereof.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Regulations on the labelling of medicinal products.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Regulations on the preparation of the Summary of Product Characteristics and the Instructions for Use.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Manufacturers of medicinal products in Latvia. Qualified person at a medicinal product manufacturing site.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Laboratory
|
2
|
Topics
|
Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products.
|
Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
LR MK noteikumi nr. 376. “Zāļu reģistrēšanas kārtība“
2.
LR MK notekumi nr. 57 “Noteikumu par zāļu marķēšanas kārtību un zāļu lietošanas instrukcijai izvirzāmajām prasībām“.
3.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
4.
Rowe, R. C. 2012. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.]. 7th ed. London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.
5.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
6.
European Directorate for the Quality of Medicines and Healthcare. 2016. European pharmacopoeia. 9th ed. Strasbourg: Council of Europe.
7.
Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
8.
Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. 2nd ed. London: Pharmaceutical Press.
9.
Volume 2B Notice to Applicants. Medicinal products for human use. 2008.
10.
Ārvalstu studentiem/For international students
11.
Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.
12.
Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
13.
European Directorate for the Quality of Medicines and Healthcare. 2016. European pharmacopoeia. 9th ed. Strasbourg: Council of Europe.
Additional Reading
1.
Pharmaceutical Capsules. 2nd edition. Edited by Fridrun Podczeck. 288
2.
Gibson, M. 2009. Pharmaceutical preformulation and formulation: A practical guide from candidate drug selection to commercial dosage form / edited by Mark Gibson. 2nd ed. Boca Ration: CRC Press, Taylor and Francis Group.
3.
Loyd, Allen Jr. Suppositories. 256 pp., 2007.
4.
Attwood, D., Florence, A. T. Physical Pharmacy. 182 pp., 2008.
5.
Jones, D. Pharmaceutics-Dosage Form and Design. 286 pp., 2008.
6.
Williams, Adrian C. Transdermal and Topical Drug Delivery. 256 pp. 2003.
7.
Labarre, D. J. P. 2011. Biomedical and pharmaceutical polymers / Denis J.-P.
Other Information Sources
1.
Eiropas Zāļu Aģentūras (EMA) izdotas vadlīnijas