Dana Evans is a Regulatory Affairs, Investigational Review Board (IRB), and Quality Assurance (QA) Professional with over 25 years of experience in clinical, academic, and investigational drugs, biologics, and device research. Extensive knowledge and experience with applicable US federal regulations within the FDA as it relates to drug evaluation and research, and biologics research.
She joined NIH/NINDS in 2011 as a Regulatory Affairs Specialist in the Clinical Trials Unit (CTU). Ms. Evans serves as the Supervisor for the Regulatory and Medical Affairs Office with in the NINDS CTU coordinating, administrating, and overseeing all FDA-regulated clinical trials sponsored by NINDS, providing trainings for drug and device clinical trials, and other duties. Her experience in Biologics for Research & Development, Quality Assurance for GMP/GCP, as an IRB Professional in Academia, Regulatory Affairs for Phase I Oncology Clinical Trials, and as a Clinical Research Associate in Cardiology trials, Ms. Evans brings a wealth of knowledge to this position. She provides guidance of human subjects’ research and assure compliance with HHS regulations and NIH policies to and for the NINDS research teams. She manages, coordinates, and prepares application packages for FDA submission, in addition to educating/training and assisting NINDS research teams in the FDA regulatory approval processes for drugs and medical devices. She oversees short-term and long-term planning of regulatory submission initiatives, device determinations, reportable events requiring specialized review, and other duties.
Ms. Evans received her Master of Arts in Law from the Regent University School of Law and Bachelor of Science – Biology from the George Washington University, Washington, DC. She is also a member of the Society of Clinical Research Associates (SOCRA).