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Introduction to the Registration of Medicinal Products
Study Course Description
Course Description Statuss:Approved
Course Description Version:9.00
Study Course Accepted:17.07.2023 13:14:44
| Study Course Information | |||||||||
| Course Code: | ZFTK_042 | LQF level: | Level 7 | ||||||
| Credit Points: | 2.00 | ECTS: | 3.00 | ||||||
| Branch of Science: | Basic Sciences of Medicine, including Pharmacy; Social Pharmacy | Target Audience: | Pharmacy | ||||||
| Study Course Supervisor | |||||||||
| Course Supervisor: | Milana Špoģe | ||||||||
| Study Course Implementer | |||||||||
| Structural Unit: | Department of Applied Pharmacy | ||||||||
| The Head of Structural Unit: | |||||||||
| Contacts: | Riga, 16 Dzirciema Street, zftk rsu[pnkts]lv, +371 67061547 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 13 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 26 | ||||
| Classes (count) | 3 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 6 | ||||
| Total Contact Hours | 32 | ||||||||
| Part-Time - Semester No.1 | |||||||||
| Lectures (count) | 13 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 26 | ||||
| Classes (count) | 3 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 6 | ||||
| Total Contact Hours | 32 | ||||||||
| Study course description | |||||||||
| 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. | ||||||||
| 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. | ||||||||
| Topic Layout (Full-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Registration of medicinal products. The history of registration of medicinal products in Latvia. State Agency of Medicines. | Lectures | 1.00 | auditorium | |||||
| 2 | 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. | Lectures | 2.00 | auditorium | |||||
| 3 | Characteristics of finished dosage forms. Basic principles of dosage form development. | Lectures | 1.00 | auditorium | |||||
| 4 | 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. | Lectures | 2.00 | auditorium | |||||
| 5 | Development of the European Pharmacopoeia. European Pharmacopoeia Commission. Working and expert groups of the European Pharmacopoeia Commission and their activities. | Lectures | 1.00 | auditorium | |||||
| 6 | National registration. Central registration. Registration of medicinal products according to the requirements of SAP and DCP. | Lectures | 1.00 | auditorium | |||||
| 7 | Characteristics of the registration documentation. Components of quality documentation and characteristics thereof. | Lectures | 2.00 | auditorium | |||||
| 8 | Regulations on the labelling of medicinal products. | Lectures | 1.00 | auditorium | |||||
| 9 | Regulations on the preparation of the Summary of Product Characteristics and the Instructions for Use. | Lectures | 1.00 | auditorium | |||||
| 10 | Manufacturers of medicinal products in Latvia. Qualified person at a medicinal product manufacturing site. | Lectures | 1.00 | auditorium | |||||
| 11 | Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products. | Classes | 3.00 | laboratory | |||||
| Topic Layout (Part-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Registration of medicinal products. The history of registration of medicinal products in Latvia. State Agency of Medicines. | Lectures | 1.00 | auditorium | |||||
| 2 | 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. | Lectures | 2.00 | auditorium | |||||
| 3 | Characteristics of finished dosage forms. Basic principles of dosage form development. | Lectures | 1.00 | auditorium | |||||
| 4 | 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. | Lectures | 2.00 | auditorium | |||||
| 5 | Development of the European Pharmacopoeia. European Pharmacopoeia Commission. Working and expert groups of the European Pharmacopoeia Commission and their activities. | Lectures | 1.00 | auditorium | |||||
| 6 | National registration. Central registration. Registration of medicinal products according to the requirements of SAP and DCP. | Lectures | 1.00 | auditorium | |||||
| 7 | Characteristics of the registration documentation. Components of quality documentation and characteristics thereof. | Lectures | 2.00 | auditorium | |||||
| 8 | Regulations on the labelling of medicinal products. | Lectures | 1.00 | auditorium | |||||
| 9 | Regulations on the preparation of the Summary of Product Characteristics and the Instructions for Use. | Lectures | 1.00 | auditorium | |||||
| 10 | Manufacturers of medicinal products in Latvia. Qualified person at a medicinal product manufacturing site. | Lectures | 1.00 | auditorium | |||||
| 11 | Preparation of the summary of product characteristics, instructions for use and labelling of medicinal products. | Classes | 3.00 | laboratory | |||||
| Assessment | |||||||||
| Unaided 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. | ||||||||
| Assessment Criteria: | Examination: • solving situations independently during practical classes; • final examination – solving situations at the end of the semester. | ||||||||
| Final Examination (Full-Time): | Exam (Written) | ||||||||
| Final Examination (Part-Time): | Exam (Written) | ||||||||
| Learning Outcomes | |||||||||
| Knowledge: | 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: | 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. | ||||||||
| Competencies: | 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. | ||||||||
| Bibliography | |||||||||
| No. | Reference | ||||||||
| 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 | ||||||||
