Art Gertel PhD
Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a number of companies including Schering-Plough, Hoffmann-LaRoche, TFS, and Quintiles, and headed departments responsible for medical writing, project management, and regulatory affairs. He also served as a Senior Research Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). He has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company and has been active in CDISC since its inception. He serves as Co-Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and Safety (ACRES). He is a Founding Member of the Global Alliance of Publication Professionals (GAPP), a Past President of AMWA and a Fellow of both AMWA and EMWA. More recently, he served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the context of clinical studies, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.