Elizabeth N. Dupras (Beth) has more than 20 years of pharmaceutical industry experience. Beth has expertise in CM&C technical writing, analytical development and an excellent working knowledge of FDA regulations, ICH guidelines and current Good Manufacturing Practices. Beth has a working knowledge of document/data management systems and eCTD submission management/publishing systems.
Beth specializes in assessing CM&C documentation for all phases of both development and postmarketing life cycle management, as well as writing the Quality documentation required for submission to Health Authorities. In addition, Beth has substantial experience in assessing general regulatory, nonclinical and clinical documentation in support of global regulatory submissions. She has coordinated the submissions and responses to queries from regulatory health authorities resulting in approval of applications.
Beth has extensive experience in preparing meeting requests and briefing packages, coordinating rehearsals and attending FDA/Sponsor pre-IND, EOP2, pre-NDA, and Type C Guidance meetings. She interacts with FDA as US agent on behalf of multiple clients.
Beth is a Regulatory Affairs Certified (RAC) professional and holds a bachelor’s degree in chemistry from St. Bonaventure University, St. Bonaventure, NY. Beth is a member of the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA).
Beth is an energetic advocate and fundraiser for breast cancer awareness and research. In particular, Beth has participated in the Susan G. Komen 3-Day, a 60-mile walk (participants walk 20 miles a day for 3 days). The 3-Day has raised over $800 million for breast cancer awareness, community outreach (screening and treatment) and research. Beth is currently training to participate her fourth 3Day in 2016 and was welcomed as a member of the 3Day Commitment Club for her ongoing support of this event.
