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Session 6 Track C: General Data Protection Regulation (GDPR) and Its Implications
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director, GSK, Canada
Although this privacy and security law was passed by the European Union (EU) in 2018, GDPR affects organizations anywhere in the world that process the personal data of EU citizens or residents. GDPR violators can face significant fines and penalties, so aside from legal, dutiful, and reputational obligations to protect patient data, there are also strong financial incentives for enterprises to be GDPR compliant. This session aims to provide insights and considerations on how to maintain GDPR compliance.
Learning Objective : - Summarize the background of GDPR
- Identify what is required for an organization to be GDPR Compliant
- Describe GDPR implications in clinical trials (verbal patient consent, data collection from patients/vendors/sites)
- Recognize potential GDPR issues concerning virtual meeting platforms (e.g., Zoom, Teams)
Speaker(s)
Bradley Norton
Managing Director and Senior Consultant, MWB Consulting Limited/Pharma Data Protection Services, United Kingdom
GDPR and It’s Impact on Running Clinical Trials in EU
Carmen DiMarino, JD
Executive Director, Assistant General Counsel, Europe, Zogenix International Limited, United Kingdom
GDPR Implications in Clinical Trials; Virtual Meeting Platforms
Samuel Allan
Principal Consultant – Data Protection, Innovatec, France
Panelist