|Good Clinical Practice||05.12.2022 09:00 - 17:00 (Mon)||virtual via ZOOM||Dr. Christian Grote-Westrick|
This workshop focuses on the conduct of clinical trials, which is explained using the BioNTech mRNA vaccine (BNT162b2) as an example. In an interactive session, the procedure will be simulated and audited by the participants.
- Structure of Clinical Trials - ICH M3 (R2), 21CFR312
- Ethics Committee - Required Documents, Reasons for rejects
- CTA – Clinical Trial Approval - PEI, BfArM, FDA, MHRA
- IMPD – Investigational Medicinal Product Dossier - Structure, CTD, Variations
- GMP Compliance for IMPs - QMS, Change Control, Risk Management, Deviation, CAPA, OGS, Complaints
- CRA monitoring at test centers - Source data verification, 21CFR11, CRF, Drug Accounting
- CRO management in clinical trials - GCP contracts, CTA inclusion, Audit NCs and according CAPAs
- SAE Reporting
- Incident Management during Clinical Trials
- Audit Simulation - 3rd Party GCP-Audit Simulation, EMA inspectors auditing sponsor
Dr Grote-Westrick studied biochemistry at the Ruhr-Universität Bochum (RUB), followed by diploma thesis at Harvard Medical School, Boston, USA. After completing his doctorate at the RUB and the Yale School of Medicine, Dr Grote-Westrick worked in industry at various biotech companies in different positions. He has been Head of QA at B.Braun since 2013.
Note: Registration of GSLS doctoral researchers has priority to non-GSLS participants. Non-GSLS participants pay a service and workshop fee of EUR 50 by bank transfer.