In this FREE webinar, Dr. Thaleia Papadopoulou and Dr. Ulrich Köllisch highlight the Data Integrity challenges and risks associated with clinical studies. Recent guidelines like the EMA Draft guideline will be discussed, real-life case studies will be presented and the current hot topics in the Life Science industry will be highlighted:

- Data Integrity in third party management (e.g., CROs)
- Sponsor responsibilities
- Real World Data and Real World Evidence

We are looking forward to your questions!
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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.
Dr. Ulrich Köllisch
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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