The University of Maryland School of Pharmacy (UMSOP), in partnership with the U.S. Food and Drug Administration (FDA), is hosting a medical devices workshop: Patient Engagement in Real World Evidence: Lessons Learned and Best Practices.
BALTIMORE, MD — The University Maryland School of Pharmacy (UMSOP), in partnership with the U.S. Food and Drug Administration, is hosting a medical devices workshop: Patient Engagement in Real World Evidence: Lessons Learned and Best Practices. The workshop on Sept. 12 aims to improve the quality of life for patients with medical devices. It is being presented by the Center for Devices and Radiological Health at the FDA; the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI); and the Center on Drugs and Public Policy at UMSOP. An agenda can be found here. Media are invited.
WHEN: Wednesday, Sept. 12, 2018, 8:30 a.m. to 4:15 p.m.
WHERE: University of Maryland School of Pharmacy, 20 N. Pine St., Baltimore, Md.
WHO: Anne C. Beal, MD, MPH, senior vice president and global head of patient solutions, Sanofi, keynote speaker; Jeffrey E. Shuren, MD, JD, director, Center for Devices and Radiological Health at the FDA, opening and closing remarks; Rachel R. Rath, MPH, deputy director, National Evaluation System for Health Technology Coordinating Center, presenting an overview of that system; and Terrie Cowley, president and co-founder, TMJ Association, giving patient and patient groups’ perspective.
Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor, who is among several UMSOP participants including workshop chair Fadia T. Shaya, PhD, MPH, professor and vice-chair for academic affairs of the Department of Pharmaceutical Health Services Research (PHSR) and associate director of UMSOP’s Center on Drugs and Public Policy; Francis B. Palumbo, PhD, professor in PHSR and executive director of the center; C. Daniel Mullins, PhD, professor and chair of PHSR and director of the PATIENTS Program, and Joey Mattingly, PharmD, MBA, assistant professor of pharmacy practice and science at UMSOP.
Stephen N. Davis, MBBS, chair of the Department of Medicine and vice president, translational science, at the University of Maryland School of Medicine, who represents the Institute for Clinical and Translational Research at the University of Maryland, Baltimore.
INFO: The purpose of the workshop is to gather lessons learned and best practices for patient engagement in evidence generation (planning, collection of data and information, analysis, and dissemination) for medical device or device and drug combination evaluation. Lessons learned will be drawn from work going on in the National Patient Centered Clinical Research Network known as PCORNet, in Coordinated Registry Networks and in other relevant community-based activities. Sessions will highlight stakeholders across the medical device ecosystem and their goal to increase patient access to safe and effective devices, such as stents, pacemakers, and artificial joints. For answers to questions about content that arise before, during, or after the workshop, email fshaya@rx.umaryland.edu or locate Dr. Shaya during the event.
CONTACT: Patricia Fanning 410-706-7946 (office) or 443-615-5811 (mobile)
