Titel | Zeit | Ort | Dozent |
---|---|---|---|
Good Clinical Practice | 15.09.2025 09:00 - 17:00 (Mo) | Online | Dr. Christian Grote-Westrick |
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.
The workshop will effectively prepare student for jobs in pharma
Working as a CRA (clinical research associate)
Planning and managing own clinical trials
Auditing and being audited in clinical trials
The workshop will be performed in two parts: first part will illustrate preparation, conduction and evaluation of clinical trials, part two will challenge participants by setting up an own clinical trials based on BioNTech´s mRNA vaccine against COVID-19.
A group of participants will then control the trial as EMA inspectors.
☒ Beginn der Promotion / Beginning of the doctorate
☒ Während der Promotion / During the doctorate
☒ Endphase der Promotion / End of the doctorate
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Dr. Grote-Westrick studied biochemistry at Ruhr-University in Bochum followed by diploma thesis at Harvard Medical School, Boston, USA.
After PhD Thesis at RUB and Yale School of Medicine Dr. Grote-Westrick started industry business at different biotech companies in various positions.
2000-2004 Biochemistry Studies (RUB, Harvard)
2004-2007 PhD in Biochemistry (RUB, Yale)
2007-2010 R&D Manager in Biotech Company imusyn
2010-2013 Production Manager in Biotech Company BDL
since 2013 Head of QA at B.Braun
Pharmaceutical QA Head, RP GDP, GMP Trainer
Freelancing GMP Trainer at international graduate schools
Member of Directors Board at European GDP Association