This seminar will be a WebEx only event.
Even after several years of development and a two year post enactment roll-in period, most US companies were caught unawares when the the European General Data Protection Regulation (GDPR) went into effect this May. In the absence of official Guidance, companies have been feeling their way along, with reactions ranging from panicked attempts to address all possibilities to reckless disregard of GDPR's implications on their business. This discussion will focus on the aspects of the GDPR that most affect clinical research and share what has been learned through dealings with European sponsors, and conversations with other affected US companies, outside law firms and offthe record thoughts from regulators on both sides of the Atlantic.
Denise Sturdy is Senior Regulatory Affairs Consultant at the Duke Clinical Research Institute. A licensed attorney, RAC certified in both the US and EU regulations, Denise has been working with national organizations on facilitating the practical application of GDPR to the conduct of multi-national human subject research by US research organizations.