Schedule of lectures of F7AMBELEG (semester B231)

Week Par Date Time Hours Room Subject Teacher
1 1 Sep 26, 2023 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 3, 2023 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 10, 2023 10:00 2 KL:B-135 None
4 1 Oct 17, 2023 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 24, 2023 10:00 2 KL:B-135 EU Regulation on Medical Devices II - Creation of technical documentation. Ing. Vojtěch Kamenský, Ph.D.
6 1 Oct 31, 2023 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 7, 2023 10:00 2 KL:B-135 EU Medical Devices Regulation IV - Vigilance and Post-market survelaince. Ing. Vojtěch Kamenský, Ph.D.
8 1 Nov 14, 2023 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 21, 2023 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 28, 2023 10:00 2 KL:B-135 None
11 1 Dec 5, 2023 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 12, 2023 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 19, 2023 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 9, 2024 10:00 2 KL:B-135 Personal data protection, specifics of personal data protection in healthcare. GDPR. Ing. Vojtěch Kamenský, Ph.D.
Total 28