1. Basic knowledge of:
1.1. socio-psychological, administrative and economic management methods;
1.2. business and economic principles and intellectual property rights, basic principles of patent interpretation;
1.3. pharmaceutical and technology development areas;
1.4. basic principles of design, construction and maintenance of industrial buildings and work environment-related utilities.
2. Understanding of:
2.1. types of active pharmaceutical ingredients and production technology;
2.2. basic principles of the development of large-scale synthesis methods;
2.3. application of biotechnology, nanotechnology in medicine production, genome medicine production, quality assurance, registration and use thereof;
2.4. types of packaging, selection principles;
2.5. drug manufacturing equipment, operating principles and use thereof, work environment and safety aspects;
2.6. basic principles of scaling;
2.7. medicine distribution preconditions, including safety, efficiency, quality and pharmaco-economic evaluation of medicine;
2.8. organization and monitoring of distribution of medicines and other healthcare products, basic principles of pharmaceutical marketing;
2.9. a qualified person’s role and responsibilities.
2.10. the role and functions of marketing and sales departments;
3. Ability to apply knowledge of:
3.1. physicochemical, toxicological properties of active substances and correlation thereof with biological activity;
3.2. origin and type of purification, characterization and analysis of active pharmaceutical ingredients and excipients;
3.3. pharmacokinetic process;
3.4. pharmaco-dynamic process;
3.5. finished dosage forms, production processes thereof;
3.6. basic principles of dosage form composition, excipients and range of options, depending on the production technology;
3.7. active pharmaceutical substances, excipients, packaging compatibility;
3.8. guidelines of the Good Manufacturing Practice (GMP);
3.9. quality systems applicable to the pharmaceutical sector;
3.10. medicine stability studies, analytical methods and validation process;
3.11. quality requirements f the production processes in both small and industrial-scale manufacture of pharmaceutical products, including standard operating prescriptions (SOPs) and supervisory standards in order to achieve the appropriate level of quality;
3.12. the relative importance of quality control testing and production monitoring to assure product quality.
3.13. various analytical methods and their appropriate application in the analysis of pharmaceutical products;
3.14. properties of borderline products and cosmetics;
3.15. the role of drug registration and registration procedures;
3.16. clinical trials from the first human tests to post-registration trials of phase 4, objectives, organization and management thereof;
3.17. personal development, management and communication psychology;
3.18. regulations governing professional activities;
3.19. principles of professional and general ethics;
3.20. basic principles of statistical data analysis;
3.21. information technologies;
3.22. document management basics;
3.23. environmental protection;
3.24. official language;
3.25. two foreign languages at a communication level;
3.26. professional terminology in the official language and at least two foreign languages;
3.27. labour protection;
3.28. employment relationship.

1. To develop the composition of finished dosage forms with respect to physicochemical properties of active substances and excipients, pharmacological and toxicological properties of active substances.
2. To select the most appropriate adjuvants, technologies, packaging materials in the development of finished dosage forms, based on research results.
3. To be able to assess the impact of production and storage conditions on the quality of medicinal products.
4. To develop and validate analytical methods for the quality assessment of active substances, excipients, materials, intermediates and finished products (finished dosage forms) according to the European Pharmacopoeia.
5. To understand the nature of different methods of analysis and apply them in pharmaceutical products analysis.
6. To standardize finished dosage forms and prepare documentation in compliance with the Good Manufacturing Practice (GMP) of medicine and ES guidelines, depending on market requirements.
7. To develop a quality control system in pharmaceutical companies.
8. To manage a quality control system in pharmaceutical companies.
9. To perform quality control (testing) and batch release and certification.
10. To assess the risks of medicine manufacturing and act in accordance with the procedures within one’s competence.
11. To understand the relative importance of quality control testing and production monitoring to assure product quality.
12. To ensure medicinal manufacturing processes in accordance with the requirements of documents governing pharmaceutical activities.
13. To ensure the compliance of the products in accordance with the requirements of technology and quality documentation.
14. To monitor the development of regulatory and binding documentation of medicine production.
15. To ensure accurate completion of binding documentation and compliance thereof with the technological process.
16. To ensure the movement of psychotropic drugs (production, storage, dispensing and inventory) in accordance with laws and regulations.
17. To be precise and observe labour protection regulatory requirements, dealing with medicinal products and active substances, schedule II, III drugs, precursors.
18. To develop, analyse and update the production consumption norms of raw materials and consumables.
19. To plan and rationally use medicinal plant capacity, material and personnel resources.
20. To develop and provide drug manufacturing and finished product delivery plans, carry out labour intensity calculations, production equipment load calculations.
21. To understand the basic principles of drug manufacturing facilities, work environment-related utilities and manufacturing equipment design, understand the importance and impact of selection, purchase, maintenance, servicing and repair thereof on the quality of the manufacturing process.
22. To understand the role of audits within a pharmaceutical company.
23. To observe amendments and act in accordance with the laws and regulations of the Republic of Latvia, EU and the Council in the field of manufacture, circulation and registration of medicine.
24. To determine the affiliation of borderline products, consider the difference between cosmetics, dietary supplements and medicines.
25. To provide storage and distribution of medicinal products in accordance with the Good Distribution Practices (GDP) and EU guidelines.
26. To understand the organization and supervision of distribution of medicines and other healthcare products, including provisions relating to the marketing (trade) of medicinal products.
27. To understand a qualified person’s role and responsibilities.
28. To understand benefits and risk assessment in relation to animal and clinical studies.
29. To ensure manufacturing and logistics of investigational medicinal products.
30. To participate in the development of clinical trial programs/protocols and presentation thereof in accordance with the requirements of the Good Clinical Practice.
31. To monitor the progress, timely conduct of clinical studies, collection of results and preparation of report in accordance with the requirements of the Good Clinical Practice.
32. To advise colleagues, healthcare professionals, students in the field of medicine production and quality assessment.
33. To continuously improve knowledge and skills and contribute to the development of the field of medicine manufacture and pharmacy in Latvia.
34. To observe the basic principles of professional and general ethics.
35. To use and comply with laws and regulations governing the pharmaceutical, chemical, medical and health care organizations and personal data protection.
36. To plan scientific research, prepare projects, participate in the implementation thereof.
37. To obtain information, using literary data and databases.
38. To determine the degree of evidence of pharmaceutical research data.
39. To work in accordance with the level of scientific and technological development on the basis of evidence-based principles.
40. To write scientific articles and reports in the field of pharmacy.
41. To build and maintain effective communication.
42. To be part of a multi-disciplinary team within one’s competence.
43. To know the official language.
44. To use professional terminology in the official language and at least one foreign language.
45. To know at least two foreign languages at the communication level.
46. To comply with environmental regulations.
47. To comply with occupational safety, electric safety, fire safety and hygiene requirements.
48. To meet the requirements of employment relationship.

1. Ability to critically evaluate the correlation between the recipe, the finished dosage form, route of administration and therapeutic effectiveness.
2. Ability to develop and standardize the formulation of medicine and prepare documentation in accordance with the European Union (EU) guidelines and the Good Manufacturing Practice of medicine.
3. Ability to control the quality of finished dosage form.
4. Ability to understand the relative importance of quality control testing and production monitoring to assure product quality.
5. Ability to understand the nature of different methods of analysis and apply them in pharmaceutical products analysis.
6. Ability to organize and ensure the manufacture of medicinal products in accordance with the requirements of Good Manufacturing Practice.
7. Ability to assess the risks of medicine manufacturing and act in accordance with the procedures within one’s competence.
8. Ability to gather documentation for human and veterinary use of finished dosage forms, registration of medical devices and dietary supplements.
9. Ability to plan and conduct pharmaceutical research of scientific value.
10. Ability to provide advise to colleagues and engage in colleague and student training in the field of medicine manufacturing and quality assessment.
11. Ability to take responsibility for one’s continuous professional growth.
12. Ability to promote the prestige of the profession and follow the principles of professional ethics and legislative regulations governing pharmaceutical, medical and health care organizations of different areas to ensure personal data protection.
13. Ability to participate in the organization, planning and supervision of clinical trials.
14. Ability to manage subordinates, consolidate a team to achieve professional goals.
15. Ability to communicate in the official language and two foreign languages.
16. Ability to observe occupational safety, fire safety and environmental safety requirements and ensure compliance thereof.
17. Ability to meet the requirements of employment relationship.
18. Ability to use information and communication technology within one’s professional activities.