vita
Stefan Winger joined INTEGRITY in October 2023 as Senior Manager Data Protection with a focus on: Design and planning of data protection relevant processes in SMEs and clinical operations.
He has
- many years of experience in advising on data protection law, especially in the assessment and preparation of data protection concepts and data protection impact assessments (DSFA) for clinical research;
- extensive consulting expertise in the design and planning of data protection-relevant processes in SMEs and clinical operations, including the related implementation of “Standard Operating Procedures” (SOPs) to optimise data protection-relevant processing activities;
- diverse experience in national, international and multi-regulatory projects, especially in the scope of application of AMG, MPGD, GCP-V;
- in-depth expertise in implementing data protection management systems (DSMS) to meet regulatory requirements in accordance with applicable laws and regulations.
Democracy means decision by those affected. (Carl Friedrich von Weizsäcker)
Focal Areas
- Data protection in the healthcare sector(clinical facilities up to maximum care providers).
- Data protection in clinical research (studies according toGCP-V, AMG, MPGD,BO and other studies)
- Data protection management systems (EN ISO/IEC 27701)
- Data protection audits (ISO 19011)
Qualifications
- Training as certified data protection officer (TÜV).
- Further training as data protection auditor
- Data protection in clinical research
- Clinical registers and data protection
- Certificate of competence in data mishaps
- TTDSG certificate of competence
- Certificate of competence in employee data protection
- Certificate of competence in data use in corporate group
Lectures
- „Incident Response Management (IRM) und Datenschutz im klinischen Kontext“, Webkonferenz CyberSecurity-Update, 09.2023
- „Datenschutz in Studien/klinische Register“, Arzt-Patienten-Symposium Morbus Wilson e.V. Heidelberg 23.09.2023