Subjects

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Introduction to the Industrial Pharmacy - GF321

Title:	Úvod do industriální farmacie
Guaranteed by:	Department of Pharmaceutical Technology (16-16210)
Faculty:	Faculty of Pharmacy in Hradec Králové
Actual:	from 2021 to 2025
Semester:	summer
Points:	0
E-Credits:	3
Examination process:	summer s.:
Hours per week, examination:	summer s.:0/28, C [HS]
Capacity:	unknown / 50 (50)
Min. number of students:	unlimited
4EU+:	no
Virtual mobility / capacity:	no
Key competences:
State of the course:	taught
Language:	Czech
Teaching methods:	full-time
Level:
Note:	course can be enrolled in outside the study plan enabled for web enrollment

Guarantor:	doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Comes under:	3.ročník 2025/26 Farmacie
Interchangeability :	GF280
Is interchangeable with:	GF280

SS schedule

Annotation -

The course introduces the structure of the pharmaceutical industry, the development of medicinal products, clinical development and bioequivalence studies of generics.<br> The course is held at Zentiva Prague, and takes place in a 3-day block. The course is provided by Zentiva's professional staff.

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)

Course completion requirements -

The condition for credit is 100% participation in practical training at the Zentiva

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)

Literature - Czech

Povinná:

Komárek, Pavel, Rabišková, Miloslava. Galenika. Praha: Galén, 2006, 399 s. ISBN 80-7262-423-7.

Doporučená:

Gad, Shayne C., (ed.). Pharmaceutical manufacturing handbook : production and processes. Hoboken, N.J.: John Wiley & Sons, 2008, s. ISBN 978-0-470-25958-0.

Last update: prepocet_literatura.php (14.08.2025)

Teaching methods -

Teaching is carried out in the form of workshops and excursions to laboratories and production (3 days)

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)

Requirements to the exam -

The subject is completed with a credit.

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)

Syllabus -

Basic information about the role of the pharmaceutical industry, the importance of generics

Structure of a pharmaceutical company, future employment opportunities for students in a pharmaceutical company and personnel support

Structure of generic drug development, project management, intellectual property

Clinical development and bioequivalence studies

Regulatory issues, pharmacovigilance

Quality assurance and GMP

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)

Learning resources - Czech

Web FaF: https://intranet.faf.cuni.cz/Studijni-materialy/KFT/?lang=cs-cz&path=%c3%bavod+do+industri%c3%a1ln%c3%ad+farmacie

Last update: Marek Josef, Ing. (30.01.2018)

Learning outcomes -

After completing the course, students will be able to use the following terms (including their commonly used abbreviations): generic drug, generic company, active ingredient (API), pharmaceutical company structure, bioequivalence, quality assurance, GMP, intellectual property, pharmacovigilance.

Learning outcomes:

Based on the knowledge and skills acquired, the student will:

• explain the role of the pharmaceutical industry

• describe the structure of a pharmaceutical company

• discuss the importance of generics

• understand the issues of generic drug development, clinical development and bioequivalence studies

• understand regulatory issues, quality assurance, GMP and the principles of intellectual property protection

Last update: Šklubalová Zdeňka, doc. PharmDr., Ph.D. (30.07.2025)