GCP – Good Clinical Practice

The workshop concentrates on clinical trials: its application, conduction and submission to au-thorities. To perform a clinical trial several authorities (ethics commission, BfArM, local authorities, EMA, FDA) must be involved and their positive feedback is required. Within the workshop all necessary steps according to GCP guidelines of clinical trials will be explained, and the role of authorities are highlighted. The workshop refers mostly to 2020 when EMA and FDA successfully authorized mRNA vaccines of BioNTech/Pfizer and Moderna.

INTERACTIVE PART: participants will perform an own clinical trial for a new mRNA vaccine. A part of the participants will take over the role of EMA inspectors who will audit this clinical trial and check completeness and compliance to GCP requirements.