Tag Archives: Clinical Trial Regulation

European Commission Issues Updated Q&A on Interplay between the GDPR and the Clinical Trials Regulation

On April 10, 2019, European Commission Directorate-General for Health and Food Safety issued a revised Q&A analyzing the interplay between the EU Clinical Trials Regulation (“CTR”) and the  EU General Data Protection Regulation (“GDPR”).  The revised Q&A takes into account the opinion of the European Data Protection Board (“EDPB”) issued on January 23, 2019, on … Continue Reading

European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”).  The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health.  The Directorate General decided to create this Q&A … Continue Reading
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