About
In this Data Integrity GCP part 2 FREE webinar, Dr. Thaleia Papadopoulou, Dr. Ulrich Köllisch and Milena Gjorgjieva will highlight the importance of Data Integrity in GCP, and risks associated with clinical studies by presenting real-life case studies on different topics. EMA and FDA regulatory expectation will be discussed for each single case study. Focus will be set on the current hot topics in GCP, including:

- Sponsor Trial Oversight
- Vendor Management & Qualification
- Audit Trail
- Access Management
- Security Controls

We are looking forward to your questions!
Presenters
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Dr. Thaleia Papadopoulou
Subject Matter Expert in GCP and Data Integrity
Dr. Thaleia Papadopoulou is conducting Data Integrity assessments in the Life Science industry and supports the implementation of Data Integrity by Design initiatives through the harmonization of Data Integrity with existing CSV frameworks. Following her PhD in Molecular Biology (Stem Cell Epigenetics) Thaleia gained experience in GCP operations through managing clinical investigator sites in diverse therapeutic settings or clinical studies. She has performed remote monitoring via utilizing a variety of widely used clinical systems and tools (EDC, IRT, CTMS, TMF) to support many aspects of GCP compliance, including data management, drug dispensation and accountability, patient eligibility, deviation reporting, pharmacovigilance and document management.
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Dr. Ulrich Köllisch
Presenter
Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous six years. He has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area and precedes special interest groups and affiliations. Ulrich combines regulatory knowledge with hands-on implementation experience for Data Integrity programs. He considers technical aspects to enable Data Integrity like processes and systems and has a focus on the human factor which is influenced by the companies’ quality culture and can be improved with awareness programs.
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Milena Gjorgjieva
Presenter
Milena Gjorgjieva is involved in building a new GCP service, for client needs, by writing articles, reviewing and updating QM assessment with current GCP regulations, and promoting our new service to clients. Following her master’s in molecular biology, Milena gained experience in GCP operations through managing clinical investigator sites in different clinical studies. She was involved in different aspects of a clinical study, from initiation of a site to maintenance, and to site’s close out, by performing remote monitoring. She has experience with widely used clinical systems and tools (EDC, IRT, CTMS, TMF) to support many aspects of GCP compliance, including data and document management, patient eligibility, drug dispensation and accountability, protocol deviation and adverse event reporting.
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