The course introduces the basic regulatory and self-regulatory framework of the pharmaceuticals and medical devices industry. Both subjects of regulation are given ample coverage, while with respect to the deeper regulation of pharmaceuticals, this topic will be slightly more prevalent. The overall approach is designed to enable students to understand or deepen their understanding of the areas with an overlap into market practice, and it is expected that lectures will include presentations by external speakers from pharmaceutical management, the medical device industry and law firms. Emphasis will be placed on developing the ability to analyse and apply legal standards as well as the ability to quickly navigate through the not often discussed legislation.
The aim of the course is to provide students with a practical insight and the ability to discuss and think critically about relevant issues.
The course is also open to students without in-depth introductory knowledge of these disciplines who are interested in the topic. However, active participation by all students and preparedness with respect to the topics posted in advance is expected.
Poslední úprava: Šicnerová Barbora, Mgr. (09.04.2025)
The course introduces the basic regulatory and self-regulatory framework of the pharmaceuticals and medical devices industry. Both subjects of regulation are given ample coverage, while with respect to the deeper regulation of pharmaceuticals, this topic will be slightly more prevalent. The overall approach is designed to enable students to understand or deepen their understanding of the areas with an overlap into market practice, and it is expected that lectures will include presentations by external speakers from pharmaceutical management, the medical device industry and law firms. Emphasis will be placed on developing the ability to analyse and apply legal standards as well as the ability to quickly navigate through the not often discussed legislation.
The aim of the course is to provide students with a practical insight and the ability to discuss and think critically about relevant issues.
The course is also open to students without in-depth introductory knowledge of these disciplines who are interested in the topic. However, active participation by all students and preparedness with respect to the topics posted in advance is expected.
Poslední úprava: Šicnerová Barbora, Mgr. (09.04.2025)
Požadavky ke zkoušce -
1. The course is concluded with an oral exam on the subject matter of the course.
2. For the successful completion of the course, a minimal attendance of 80 % (i.e., the attendance at at least 8 seminars) is required apart from submitting essays.
3. Students will be partially evaluated based on their activity in seminars, the quality of the final essay and its presentation.
Poslední úprava: Šicnerová Barbora, Mgr. (09.04.2025)
1. The course is concluded with an oral exam on the subject matter of the course.
2. For the successful completion of the course, a minimal attendance of 80 % (i.e., the attendance at at least 8 seminars) is required apart from submitting essays.
3. Students will be partially evaluated based on their activity in seminars, the quality of the final essay and its presentation.
Poslední úprava: Šicnerová Barbora, Mgr. (09.04.2025)
Sylabus -
The course covers primarily the following topics:
- General Introduction to pharmaceuticals and medical devices markets
- Clinical trials
- Distribution
- Reimbursement
- Advertising and marketing
- Relations with healthcare professionals
- Compliance
- Self-regulation
- Personal data protection with focus on pharmaceuticals and medical devices business activities
- Patient finding initiatives and patient support programs
Poslední úprava: Šicnerová Barbora, Mgr. (28.08.2025)
The course covers primarily the following topics:
- General Introduction to pharmaceuticals and medical devices markets
- Clinical trials
- Distribution
- Reimbursement
- Advertising and marketing
- Relations with healthcare professionals
- Compliance
- Self-regulation
- Personal data protection with focus on pharmaceuticals and medical devices business activities
- Patient finding initiatives and patient support programs
Poslední úprava: Šicnerová Barbora, Mgr. (28.08.2025)
Studijní opory -
Basic literature:
1. SCHENKOVÁ, K. a LASÁK, J. Compliance v podnikové praxi. V Praze: C.H. Beck, 2017. Právní praxe. ISBN 978-80-7400-668-5.
2. KRÁL. Farmaceutické právo. Praha : Erudikum, 2014. ISBN: 978-80-905897-0
3. NULÍČEK, Michal a kol. GDPR/Obecné nařízení o ochraně osobních údajů. V Praze: Wolters Kluwer, 2018. Praktický komentář. ISBN 978-80-7598-068-7.
4. SVEJKOVSKÝ, VOJTEK, ARNOŠTOVÁ. Zdravotnictví a právo. V Praze: C. H Beck, 2016. ISBN: 978-80-7400-619-7
Basic legislation(always in wording in force and effect as on the date of examination):
1. Act No. 40/2009 Coll., Criminal Code, as amended
2. Act No. 89/2012 Coll., Civil Code, as amended
3. Act No. 40/2009 Coll., on the Regulation of Advertising and on the Amendment of Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended
4. Act No. 375/2022 Coll., on Medicinal Products and In Vitro Diagnostic Medicinal Products (Act on Medicinal Products), as amended
5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
6. Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
7. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
8. Guidelines of SÚKL for Advertising
9. AIFP Code of Conduct
Other legal regulations(always in wording in force and effect as on the date of examination):
1. Act No. 141/1961 Coll., Code of Criminal Procedure, as amended
2. Act. No. 262/2006 Coll., Labour Code, as amended
3. Act. No. 234/2014 Coll., on Civil Service, as amended
Poslední úprava: Šicnerová Barbora, Mgr. (29.08.2025)
Basic literature:
1. SCHENKOVÁ, K. a LASÁK, J. Compliance v podnikové praxi. V Praze: C.H. Beck, 2017. Právní praxe. ISBN 978-80-7400-668-5.
2. KRÁL. Farmaceutické právo. Praha : Erudikum, 2014. ISBN: 978-80-905897-0
3. NULÍČEK, Michal a kol. GDPR/Obecné nařízení o ochraně osobních údajů. V Praze: Wolters Kluwer, 2018. Praktický komentář. ISBN 978-80-7598-068-7.
4. SVEJKOVSKÝ, VOJTEK, ARNOŠTOVÁ. Zdravotnictví a právo. V Praze: C. H Beck, 2016. ISBN: 978-80-7400-619-7
Basic legislation(always in wording in force and effect as on the date of examination):
1. Act No. 40/2009 Coll., Criminal Code, as amended
2. Act No. 89/2012 Coll., Civil Code, as amended
3. Act No. 40/2009 Coll., on the Regulation of Advertising and on the Amendment of Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended
4. Act No. 375/2022 Coll., on Medicinal Products and In Vitro Diagnostic Medicinal Products (Act on Medicinal Products), as amended
5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
6. Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
7. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
8. Guidelines of SÚKL for Advertising
9. AIFP Code of Conduct
Other legal regulations(always in wording in force and effect as on the date of examination):
1. Act No. 141/1961 Coll., Code of Criminal Procedure, as amended
2. Act. No. 262/2006 Coll., Labour Code, as amended
3. Act. No. 234/2014 Coll., on Civil Service, as amended
Poslední úprava: Šicnerová Barbora, Mgr. (29.08.2025)
