LFU:online

Monitoring safety; cellular toxicology (e.g. liver, long QT, hypersensitivity reactions), DSUR/PSURs/USM/clinical hold

•    General considerations – Safety Population
•    Epidemiology of Study population
Safety Concern establishment/prediction of safety profile
Reporting requirements, SUSARs, PADERs, DSURs
•    Signal Detection Signal Detection activities and methods/Safety Science activities
•    Urgent Safety Measures, temporary halt, early termination
•    Specific Monitoring requirements, additional Risk minimization measures and populations not studied
•    Risk management plan (RMP): concept, development and maintenance
•    Self-centered learning content

Vorlesung (Computer-unterstützte visualisierte Präsentation, online Handouts)

schriftlich

Modules 1 and 2

5 UE self centered learning content