The Law & Ethics of International Clinical Trials
Wednesday, June 19, 2013
12:00 p.m. - 1:30 p.m.
American University Washington College of Law
4801 Massachusetts Avenue, NW, Washington DC
6th Floor Student Lounges
John Williford, Esq. Associate at the Clinical Technology Transfer Group
Sarah Kiskaddon, MA, JD. Director of the Association for the Accreditation of Human Research Protection Programs
James Armbrust, JD. Head of Clinical Trial Business Operations, MedImmune
Kate Duffy Mazan, Esq. Founding member of the Clinical Technology Transfer Group
Drug development and testing is no longer contained solely within the borders of a particular country. Laws and regulations from around the world may apply to the ethical, scientific, and intellectual property aspects of a clinical trial for the protection of patients, clinical trial sponsors (pharmaceutical/biotechnology/medical device company), and contract research organizations (CROs). This panel will explore how to navigate the legal and scientific maze to successfully organize, execute, and conclude a clinical trial. The combined expertise of the panel includes international negotiation of clinical trial agreements, ethical considerations, intellectual property, risk management and export control regulations, informed consent, and ethics.