Yvonne Krupke
Berufserfahrung
- Monitoring and site management of clinical trials phase I to IV (oncology, stroke, M. Parkinson, cardiology, endocrinology, respiratory diseases)
- Study coordination and support of project management
- Coordination and supervision of a CRA team
- Audit preparation and participation
- Study documentation and maintenance of clinical databases according to ICH-GCP, German Drug Law and SOPs
- Regulatory affairs
- CRF-design and creation
Employments
- since April 2002: freelance CRA
- 10/2000 – March 2002: ClinAssess Ltd., Leverkusen
- 09/1997 – September 2000: INPUT Ltd., Aachen
- 10/1991 – September 1997: Institut für numerische Statistik Ltd., Cologne
- 08/1990 – September 1991: Institute for Rehabilitation research, Norderney
Education / Qualification
- 2009: Preparation and wrap-up of audits and inspections
- 2008: Clinical trials with childen
- 2008: A Guide to ICH-GCP
- 2007: Comprehensive body of legislation for conduction of clinical trials in Germany (Aachen), Clinical Research with Medical Devices (Potsdam)
- 2006: 12./14. AMG-amendment, GCP-regulation (Aachen), GCP-inspections (Aachen), BVMA Annual Meeting (Munich)
- 2005: RECIST (Amsterdam), Business English (Bochum), Medicine for Monitors (Konstanz)
- 2004: DGGF Annual Meeting (Darmstadt)
- 2003: Diabetes mellitus (Mainz), GCP refreshment (Neuss), New Laws and Trends in Clinical Research (Eschborn)
- 2001: Data management for valid data in clinical studies, the intersection between monitoring and evaluation (Frankfurt/Main)
- 2000: How the collaboration between the pharmaceutical industry and CROs can be optimised: typical difficult situations from the point of view of the sponsor (Düsseldorf), MS Access Intermediate Course (Leverkusen), The Clinical Study in the IT Era (Munich)
- 1999: The use of data banks to acquire information for the pharmaceutical industry (Cologne)
- 1998: GCP for study coordinators (Munich), Pagemaker (Aachen)
- 1997: MS Excel, MS Access (Aachen)
- 1991 – 1997: internally organized trainings regarding indications, law and guidelines
- 1988 – 1990: School for medical documentation, Ulm University
- 1988: School leaving examination
