GDPR: Considerations for Global Life Sciences Companies

Karen Sewell is an attorney practicing data privacy and security law, including global and cross-border counseling, privacy program design and maintenance and data breach response. She leads AbbVie Inc.'s global privacy team providing support to all of AbbVie's departments across all jurisdictions. Karen began her career in private practice at Baker & McKenzie and McGuireWoods practicing in global disputes, antitrust and general commercial litigation.

She holds a JD from the College of Law at the University of Illinois Urbana-Champaign and a BS in Journalism from Northwestern University.

Peter A. Blenkinsop is a Partner at Drinker Biddle Reath LLP and advises clients on data privacy, research compliance, and e-health. He co-chairs the firm’s Information Privacy, Security & Governance practice. Peter represents clients in the life sciences, health, nutrition, and technology sectors, among others.

Peter’s focus on data privacy and security law began well over a decade ago in the run up to implementation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Since then, his practice has expanded well beyond health information privacy to data privacy and security generally. He advises companies on compliance issues raised by US federal and state privacy laws such as the Children’s Online Privacy Protection Act (“COPPA”), the CAN-SPAM Act, the Telephone Consumer Protection Act, and the Junk Fax Prevention Act. In this role, he assists clients in identifying privacy and security risks and developing information governance programs.

Peter also advises companies on compliance with international data transfer issues under the EU Data Protection Directive and other foreign privacy laws. He has assisted a number of multinationals in the development of their global privacy compliance programs. He regularly monitors and reports to clients on developments in data privacy laws worldwide.

As a member of the life sciences and pharmaceutical practices, Peter assists health industry clients with legal issues related to medical research, including clinical trials compliance, collection and use of human biological samples, and international research requirements. He advises companies on compliance with the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) human subject protection regulations, as well as guidelines for medical research issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), World Health Organization, and World Medical Association.

Peter also advises companies on compliance with FDA and Federal Trade Commission (FTC) requirements related to the marketing of drugs, devices, and consumer healthcare products. This includes advising companies on development of mobile health applications, health websites, and health and fitness wearables.

Peter has a BA from Yale University and a JD from Georgetown University Law Center.