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

Webinar - 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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Price: £200.00

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Thursday October 31st 2019 10.00 EST, 15:00 GMT (approx 60 minutes)

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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