Schedule of lectures of F7AMBELEG (semester B241)

Week Par Date Time Hours Room Subject Teacher
1 1 Sep 24, 2024 10:00 2 KL:B-135 Fundamentals of law, legislative process in EU, overview of basic sources of medical law. Ing. Vojtěch Kamenský, Ph.D.
2 1 Oct 1, 2024 10:00 2 KL:B-135 General requirements for placing products on the EU market, technical standardization. Ing. Vojtěch Kamenský, Ph.D.
3 1 Oct 8, 2024 10:00 2 KL:B-135 None
4 1 Oct 15, 2024 10:00 2 KL:B-135 EU Regulation on Medical Devices I - Basic principles of placing medical devices on the market, rights and obligations of entities when placing medical devices on the market. Ing. Vojtěch Kamenský, Ph.D.
5 1 Oct 22, 2024 10:00 2 KL:B-135 EU Regulation on Medical Devices II - Creation of technical documentation. Ing. Vojtěch Kamenský, Ph.D.
6 1 Oct 29, 2024 10:00 2 KL:B-135 EU Regulation on Medical Devices III - Conformity assessment and notified bodies. Ing. Vojtěch Kamenský, Ph.D.
7 1 Nov 5, 2024 10:00 2 KL:B-135 EU Medical Devices Regulation IV - Vigilance and Post-market survelaince. Ing. Vojtěch Kamenský, Ph.D.
8 1 Nov 12, 2024 10:00 2 KL:B-135 Notification of MD and specifics of national regulation of medical device in european countries. Ing. Vojtěch Kamenský, Ph.D.
9 1 Nov 19, 2024 10:00 2 KL:B-135 Intellectual property protection options. Types of industrial property. Patent and utility model granting process. Ing. Vojtěch Kamenský, Ph.D.
10 1 Nov 26, 2024 10:00 2 KL:B-135 None
11 1 Dec 3, 2024 10:00 2 KL:B-135 Legal metrology in healthcare, metrological confirmation. Legislative framewok of metrology in EU and CZE. Ing. Vojtěch Kamenský, Ph.D.
12 1 Dec 10, 2024 10:00 2 KL:B-135 Purchase of medical equipment - issues of public procurement, legislation framewrok in EU and CZE. Ing. Vojtěch Kamenský, Ph.D.
13 1 Dec 17, 2024 10:00 2 KL:B-135 Legislative framework for assessing the quality and safety of health services (accreditation of medical facilities). Ing. Vojtěch Kamenský, Ph.D.
14 1 Jan 7, 2025 10:00 2 KL:B-135 Personal data protection, specifics of personal data protection in healthcare. GDPR. Ing. Vojtěch Kamenský, Ph.D.
Total 28