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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)
GDPR and It’s Impact on Running Clinical Trials in EU
Bradley Norton
MWB Consulting Limited/Pharma Data Protection Services, United Kingdom
Managing Director and Senior Consultant
GDPR Implications in Clinical Trials; Virtual Meeting Platforms
Carmen DiMarino, JD
Zogenix International Limited, United Kingdom
Executive Director, Assistant General Counsel, Europe
Panelist
Samuel Allan
Innovatec, France
Principal Consultant – Data Protection