UA-143952650-1

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

The interplay between the EU Clinical Trials Regulation, Clinical Trial Directive and  the General Data Protection Regulation
Product Code: The interplay between the EUCTR and GDPR
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Recorded webinar - The interplay between the EU Clinical Trials Regulation, Clinical Trial Directive and the General Data Protection Regulation
A recording of the webinar held live on 4 September 2019. Watch it online.

  • 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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