ISPOR 2019
May 18-22, 2019
New Orleans, Louisiana
ISPOR is recognized globally as the leading educational and scientific organization for health economics and outcomes research (HEOR) and its use in healthcare decisions. ISPOR 2019 will feature three thought-provoking plenary sessions and more than 2100 presentations in the form of workshops, issue panels, forums, symposia, and podium and poster presentations on innovative research methods, health policy development using outcomes research, patient preferences, real-world data, and clinical-, economic-, and patient-reported outcomes. The conference will take place in New Orleans, Louisiana at the Orleans Ernest N. Morial Convention Center.

Jill E. Sackman, DVM, Ph.D., DACVS., senior manager at Exponent, will moderate Proactive Post-Market Surveillance, 510(K) Update, And Real-World Evidence: Can It Improve Patient Safety, Outcomes And Provide A Competitive Edge? on Monday at 3:45 p.m.

The 510(k) process has been under scrutiny for its need to be more reflective of today’s technology standards. Regulatory reform has been prioritized to shift from a passive approach toward active surveillance. As part of this focus, the FDA established NEST, which relies on real world evidence (RWE) for devices. Proposed reforms indicate additional post-market safety requirements for devices cleared via the 510(k) process. The FDA has selected women’s health as one of the focus areas for these regulatory reforms.

Dr. Jill Sackman will be leading a panel of leading experts in debating the impact of RWE and proactive post-market surveillance on medical product innovation, patient access and safety. As the FDA has selected women’s health as a focus area, a thought leading physician will be discussing the impact of the proposed changes on patient safety, outcomes, and access to care and specifically impact to women in diverse/minority groups; a prominent litigation attorney, will lead the discussion on the impact of using RWE on patient safety as well as medical product liability that may be partially driving regulatory changes. She will address new liability issues that may arise as patient data are collected and used. A medical device industry executive will speak to the impact of changing predicate comparators and technology standards in the 510(k) process and address the cost/value of post-market data and the impact these changes may have on the speed with which innovative technologies reach the market.

Jordana Schmier, senior managing scientist at Exponent, will also be in attendance.

Exponent is a proud sponsor of ISPOR 2019.

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