Live Webinars

WEB190116 - GDPR Implementation in Clinical Trials

Jan 16, 2019 12:00pm ‐ Jan 16, 2019 1:00pm


Description

This 60-minutes session is aimed at providing an overview of the General Data Protection Regulation (GDPR) and translating its specific requirements into a clinical trial environment. The session will provide useful information in regards to different roles of various clinical trial parties and their responsibilities. Attendees can gain knowledge on how this impacts them and their organizations, and learn about the measures that they need to have in place to comply with the GDPR. Additionally, the current status of different EU country implementations of this regulation will also be covered in general, as well as the different positions of EU regulatory bodies in regards to clinical trial requirements. This session will provide practical solutions to GDPR implementation within the clinical trial environment. Attendees will be provided with a GDPR Assessment Checklist for both Controllers and Processors (and an additional document on Roles & Responsibilities, upon request).

Learning Objectives:

  • Understand general requirements introduced by the General Data Protection Regulation (GDPR)
  • Understand its effects on clinical trials
  • Know specifically which steps need to be taken to ensure clinical trials are GDPR compliant

Speaker(s):

  • Natasa Spasic, Quality and Compliance Officer, Data Protection Officer, Pharm-Olam International Deutchland

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