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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
To ensure the safety of marketed medical devices, manufacturers and regulators typically rely upon surveillance methods through which patients, physicians and others report adverse events through an established system. Such feedback is critical to safety monitoring but is limited in its ability to quickly identify new risks and changes in frequency for known risks.
To address these concerns, an Active Surveillance Task Force was established with the charge of advancing and launching active surveillance projects, and the goal of continuously generating, accessing and evaluating device performance in order to detect emerging safety signals more quickly. Task Force membership includes key stakeholder representation from patients, clinicians, health systems, FDA, payers and the medical device industry.
This active surveillance work builds upon central orchestration strategies for data curation, data quality and data analytics, as well as established surveillance operations with repeatable, scalable digital workflows. The development process addresses six key areas: architecture, interoperability, analytics, data management, compliance and stakeholder collaboration. The Task Force also seeks to extend an established Common Data Model (CDM) for device active surveillance. Finally, an IT Cloud Working Group has been formed and is charged with designing and building the Active Surveillance Cloud Infrastructure platform, which will be used to facilitate the collection and analysis of real-world data (RWD) for medical device safety signal detection and assessment.
The Active Surveillance Cloud Infrastructure approach intends to allow for the continuous monitoring of RWD and provide stakeholders the opportunity to make informed, real-time decisions on behalf of patients.
After this program, participants will be able to:
Medical device professionals with an interest in post-market surveillance for medical devices. Health systems and researchers with an interest in real-world data curation, quality and analytics in a federated environment. Patient groups and regulators focused on medical device safety and effectiveness.
Omar Badawi, PharmD, MPH, FCCM, is the director of medical device safety at NESTcc, where his primary role is in the development of an active surveillance program for medical device safety. Prior to NESTcc, he led the research for developing product-related predictive algorithms and decision support tools for acute care telehealth systems at Philips Healthcare and was the program manager for the Philips eICU Research Institute which supports collaborative research between industry, academia and clinicians using de-identified clinical data representing over six million ICU patients. He is also an adjunct assistant professor with the University of Maryland School of Pharmacy and a research affiliate at the Massachusetts Institute of Technology.
Omar earned a master’s in public health with a focus in epidemiology and biostatistics from the Johns Hopkins Bloomberg School of Public Health and is also a fellow of the American College of Critical Care Medicine.
Shaun Grannis, MD, MS, FAAFP, FACMI, FAMIA, Vice President , Data and Analytics, Regenstrief Institute
Vice President , Data and Analytics, Regenstrief Institute, Inc.; Research Scientist, Center for Biomedical Informatics, Regenstrief Institute, Inc.; Regenstrief Chair in Medical Informatics, Indiana University School of Medicine; Professor of Family Medicine, Indiana University School of Medicine
Dr. Shaun Grannis collaborates closely with national and international public and population health stakeholders to advance the technical infrastructure and data-sharing capabilities in varying settings. His research is focused on improving discovery and decision support in a variety of contexts by developing, testing, and implementing innovative approaches for data integration, patient matching, predictive modeling and other novel data science use cases, including developing novel population health data frameworks supporting fusion of community and social determinants of health with clinical data, as well as leveraging machine learning-based models to improve discovery and decision support in a variety of contexts.
Dr. Grannis has been a part of Regenstrief Institute since 2001 when he began a National Library of Medicine sponsored medical informatics fellowship. He became the Associate Director of the Clem McDonald Center for Biomedical Informatics at Regenstrief in 2015 and was appointed Director in 2017. He assumed the role of Vice President in 2019.
Maria Gmitro, BCPA, President and Co-Founder, Breast Implant Safety Alliance
Maria Gmitro holds a Master's Degree in Instructional/Educational Technology from the University of Central Florida and is the Director of Community Outreach & Patient Advocacy for TrackMy Solutions, a medical device tracking/patient alerting company. Maria experienced illness from newly FDA approved breast implants and regained health upon removal. After healing, she decided to take action by supporting other women suffering from breast implant illness and BIA-ALCL through various support groups. She testified in front of the FDA at the most recent hearing on the safety of breast implants in March 2019.
Maria is President and co-founder of Breast Implant Safety Alliance (BISA Nonprofit). In September of 2019, she and her BISA organization were the first patient advocacy group given a booth at the American Society of Plastic Surgeons “Plastic Surgery The Meeting.” Through her experience, she learned of the greater issues with medical devices and advocates in DC for medical device safety. She serves as a breast implant representative for Medical Device Problems Advocacy of ASHES Nonprofit. She also serves as a breast implant patient representative for the National Center for Health Research’s Breast Implant Working Group, the American Society of Plastic Surgeons Patient Group and the Breast Device Collaborative Community.
Maria currently lives in Charleston, South Carolina with her husband and two daughters. She hopes to raise public awareness because individuals need accurate information to make informed health decisions.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance following the workshop.