1.00pm Introduction
1.10pm History of changes in clinical trial conditions during the pandemic
1.30pm Requirements and options for adaptation of study conditions during the pandemic respecting EMA and diverse national guidances on different trial aspects, e.g.,
> Informed consent
> IMP handling
> Decentralisation of study activities
> Protocol deviations
> Pharmacovigilance
> Monitoring
> Auditing and Inspections
> Communication with ethics committees and competent authorities
3.00pm Break
3.30pm Lessons learned: How to plan a clinical trial that will start in September 2021?
4.20pm Joint Exercise:Risk Management in a clinical trial in times of a pandemic
5.00pm Final multiple-choice test
5.30pm End of the Training
Ingrid Klingmann MD, PhD, FFPM, FBCPM, GFMD
Expert in Medicines Development Planning and Site Management Support
Chairman, European Forum for Good Clinical Practice (EFGCP)
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