GCP – Good Clinical Practice

TitleTimeRoomTeacher
Good Clinical Practice15.09.2025 09:00 - 17:00 (Mon)OnlineDr. Christian Grote-Westrick
Keywords: 
Clinical Trials, mRNA vaccines, Working as CRA – clinical research associate
Course Description: 

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

Course aims: 

Working as a CRA (clinical research associate)
Planning and managing own clinical trials
Auditing and being audited in clinical trials

Teaching methods: 

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.

This course fits doctoral candidates in the following phase: 

☒ Beginn der Promotion / Beginning of the doctorate
☒ Während der Promotion / During the doctorate
☒ Endphase der Promotion / End of the doctorate

Participation requirements: 

NONE

Technical requirements: 

NONE

Course preparation: 

NONE

Category: 
Fachspezifische Veranstaltung
Event type: 
Seminar/Workshop
Organizer: 
Graduate Center of Life Sciences
Responsibility for event: 
Hauptverantwortung
Format: 
Digital/Online
Course Language: 
EN
Course Capacity (Max): 
25
Course capacity (Min): 
5
Duration in hours: 
6.50
Trainer: 
Dr. Christian Grote-Westrick

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