TOPIC: General Data Protection Regulation (GDPR), the New European Privacy Law
TOPIC DESCRIPTION: The EU General Data Protection Regulation (GDPR) has wide-ranging implications for the collection, processing and use of personal data. Among other things, the GDPR extends jurisdiction over US companies processing personal data of EU residents in the US and elsewhere outside the EU. It also imposes more stringent requirements for data subject consent to the processing and use of their personal data and requires that data controllers and data processors have formal written agreements with respect to the processing and use of personal data. GDPR requirements affect clinical trial agreements with study sites, ICFs, CRO agreements, and other general business agreements.
This presentation will provide an overview of the GDPR and a deeper dive into its requirements as they relate to the conduct of clinical trials in the EU.
SPEAKER: Deborah Elvins
SPEAKER BIOGRAPHY: Deborah Elvins is a partner in Adkins Black LLP, focusing her practice on business and legal services for life-sciences companies in the early to mid-stage levels of development. Deborah's practice includes a wide range of services, from advising boards of directors to negotiating and drafting in- and out-license agreements, manufacturing agreements, CRO and clinical trial agreements and other life sciences-specific transactions to general business advice and transactional work.
Before joining Adkins Black, she was vice president of legal affairs for Dendreon Corporation, where she p[provided legal services and intellectual property and human resources management. Prior to that, she was the managing partner of the Seattle office of Stoel Rives LLP, where she practice general corporate and business law with an emphasis on non-profit, healthcare and technology businesses.
Deborah earned and undergraduate degree in history from the University of Washington and her J.D. from the University of Washington School of Law.
WHO: Clinical operations and management, regulatory affairs, legal.
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification