Former FDA Executive Jamie Page Joins 3D Communications FDA Regulatory and Advisory Committee Preparation Team
Washington, DC—3D Communications LLC announced today the continued expansion of its FDA Regulatory and Advisory Committee preparation services with the hiring of former FDA reviewer and project manager Jamie Waterhouse Page.
Jamie Page worked at the Food & Drug Administration (FDA) for seven years in the Center for Devices and Radiological Health (CDRH). At CDRH, she held positions as Lead Reviewer and Project Manager, working in the Division of Cardiovascular Devices and Neurological and Physical Medicine Devices. Jamie was also a Designated Federal Officer responsible for coordinating Advisory Committee meetings and was involved in Q-Submissions, Pre-IDE, Early Feasibility Study, Expedited Access Program, and Appeals meetings between the FDA and Industry.
“Jamie’s recent in-the-trenches experience with FDA interactions and meetings at every stage of product development will provide valuable insight to our clients,” said Jim DiBiasi, 3D Communications Co-Founder. “In addition, her work with FDA Advisory Committee meetings will make her an integral part of 3D’s Advisory Committee team.”
Jamie also brings industry experience to her new role at 3D. Before joining FDA, Jamie worked in industry as a Field Clinical Engineer at a start-up medical device company, responsible for device programming and technical support during implantation and follow-up visits with patients enrolled in clinical trials. Visit Jamie’s blog.
Over the last 15 years, 3D Communications has established itself as a global leader in healthcare communications specializing in helping companies navigate the U.S. regulatory approval process.
3D Communications is preeminent in preparing pharmaceutical, biotech and device companies for regulatory meetings with the FDA, EMA, and other regulatory agencies. Our services include: developing strategy; creating content: including messaging, scripting, slides, Q&A and briefing books; coaching teams on delivery; and executing realistic mock rehearsals. We have also developed proprietary processes and technology tools to support these meetings. 3D has written The FDA Clinical Submission Survival Manual, and The FDA Advisory Committee Survival Manual: A Step-by-Step Guild to Preparing for a Successful Meeting. For more information, visit www.3dcommunications.us.