740861 VO Regulatorisches Umfeld in Europa
Sommersemester 2023 | Stand: 23.03.2023 | LV auf Merkliste setzen· including EU-Commission, European Council, EDQM, EMA, national agencies
· Gain an understanding of the EU-network, cooperation and interactions
· Learn how to operate in the EU-network - the regulatory field for medicinal products
· Learn how to interact with regulatory agencies in a digital world
· The European Medicines Network - EC, EMA, NCAs (National Competent Authorities), EDQM
o Who we are
o How we work
· Role, responsibility and structure of the EMA and NCAs
· Committees of the EMA and European experts database
· Interaction between EMA and NCAs
· Transparency and disclosure of Information
· EU Telematics – network / system
· EDQM
Vorlesung (Computer-unterstützte visualisierte Präsentation, online Handouts)
schriftlich
Modules 1 and 2
7.3.2023: 9-17 Uhr M.01.470
9.3.2023: 09:30-12:00 Uhr online
17.3.2023: 9-11:30 Uhr M.01.392
Prüfung am 11.4.2023: 9-11 Uhr: M.01.392
9.3.2023 9:30-12 Uhr , online
17.3.2023 9-11:30 Uhr , M.01.392
Prüfung: 28.3.2023 10-12 Uhr, L.03.121
Ersatzprüfung: 11.4.2023: 9-11 Uhr, M.01.392