Webinar - The interplay between the EU Clinical Trials Regulation, Clinical Trial Directive and the General Data Protection Regulation

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Webinar - The interplay between the EU Clinical Trials Regulation, Clinical Trial Directive and

the General Data Protection Regulation

• These two ‘powerful’ Regulations in Europe affect the way in which clinical trials are performed.
• The webinar is based on recent guidance from the European Commission and European Data Protection Board.
• GDPR impacts trials being conducted under the current Clinical Trials Directives (CTD), how to manage this.
• Also covered ….  how data protection rules (GDPR) should be applied when performing a trial in accordance with EU Clinical Trial Regulation 2014/536 (CTR) and CTD .
• Legitimate basis for processing, GDPR v CTR consent implications, data storage, secondary use of data.
• The interplay between CTR and GDPR in relation to safety data – is pseudonymization the answer?

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