The FDA established a public docket to solicit input on ongoing efforts to enhance mechanisms for Patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. This concept was directly informed by the public feedback solicited through the prior public docket regarding FDA's stakeholder engagement responsibilities outlined by the Food and Drug Administration Safety and Innovation Act (FDASIA). The purpose of this notice is to outline FDA's proposal for the future of patient engagement at the Agency so that the perspectives of patient communities can be better captured. To read the entire Federal Register Notice and to make comments electronically.
Interested? Join DIA Patient Engagement Community Meeting on Monday, April 10, 2017
Raina Olexa will present information to the DIA PEC regarding the FDA for the establishment of an Office of Patient Affairs and the call for public comments (see above brief and link). Raina is a Director of Quality Assurance for late phase research at QuintilesIMS, and the founder Lakeside Regulatory, Inc., a non-profit organization dedicated to empowering the public to engage in the pharmaceutical regulatory process. Lakeside Regulatory’s projects focus on patient advocacy, patient engagement, and public education about global health authority regulations that impact the availability, safety and effectiveness of life saving medicines.
Raina holds a Master of Science degree in Bioscience Regulatory Affairs from Johns Hopkins University, a Bachelor of Science degree in Biobehavioral Health from Pennsylvania State University, and is currently completing a Doctoral degree in Regulatory Science at University of Southern California, with a disertation specialization in patient engagement practices in clinical research. Ms. Olexa has worked in the medical research and pharmaceutical fields for over 15 years, gaining experience in pre-clinical, clinical and commercial manufacturing aspects of the drug development lifecycle.
Check out upcoming events of the DIA PEC and get a chance to provide your contribution to the Patient Engagement Community!