Presented by: Aarthi B. Iyer, JD, MPH, CIP, Managing Director & Senior Regulatory Attorney at Kinetiq, and David C Babaian, JD, LL.M, CIP, Senior Consultant & Senior Regulatory Attorney at Kinetiq

 

This webinar is presented by Kinetiq Research and Technology Consulting. Kinetiq and its parent company Quorum are now part of Advarra. For more information on the acquisition, click here.

 

The European Union’s (EU) General Data Protection Regulation (GDPR) catalyzed significant changes to European privacy law when it became effective in May 2018. By now, the wide-sweeping, almost mystical, ramifications are becoming apparent. Beyond the EU, GDPR’s impact is far-reaching. It is vital for all research-related organizations to understand and analyze how this data privacy measure may impact your research activities.

GDPR data privacy regulations do not just apply to research-related organizations in the EU. The data protections cover all entities if they process personal data—not merely participant research data—that originates within the EU. Join this webinar to understand the regulatory impact of GDPR for your organization—including governance of data processing and sharing, data subject notice and informed consent, and interplay with US regulations. It will be crucial in contouring your research roadmap and operations more broadly to ensure compliance.

Learning Objectives:

  1. Outline EU GDPR scope, key definitions and requirements, and regulatory impact on researchers and research organizations
  2. Evaluate operational implications of GDPR regarding protection parameters around informed consent, future research, research transparency, data processing and sharing, data transfer outside the EU, as well as business privacy policies and responsibilities
  3. Highlight GDPR requirements in contrast to US data privacy, security, and confidentiality regulations
  4. Offer potential solutions for updating policies, procedures, and practice for compliance with GDPR

Audience:
Content applies to roles at study sponsors, CROs, institutions, and research sites, including: research executives, managers, coordinators, IRB chairs, managers & administrators; legal counsel executives and privacy/compliance professionals; and principal investigators

Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.

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