For patients on Medicare, the majority of whom are over age 65, time matters. However, newly published research from the Stanford Byers Center for Biodesign shows that patients can wait up to 5 years after FDA authorization to access new medical technologies. Instead, a well-designed transitional coverage program could greatly accelerate patients’ access to care, while reducing the overall cost burden on our healthcare system. This program would also encourage innovation in areas of critically important unmet clinical needs. The Duke-Margolis Center for Health Policy has recommended the addition of several key elements to a transitional coverage pathway, highlighting the need for early engagement between stakeholders to inform and guide evidence development and appropriate use of novel technologies. Please join us to explore these findings and hear the perspectives of physicians, innovators and CMS stakeholders on this important initiative to advance patient care.
Professional Services
Calendar of Events
|
Monday
|
Tuesday
|
Wednesday
|
Thursday
|
Friday
|
Saturday
|
Sunday
|
|---|---|---|---|---|---|---|
|
1 event,
–
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
0 events,
|
|
0 events,
|
0 events,
|
0 events,
|
1 event,
–
In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes. NAMSA invites you to attend this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval. |
0 events,
|
0 events,
|
0 events,
|
|
0 events,
|
0 events,
|
2 events,
Register today for MDMA’s flagship event, the 2022 MDMA Annual Meeting, which will be held, IN PERSON, April 27-29th. Hear from Congressional, Federal Agency and industry leaders and visit Capitol Hill during their popular Congressional Fly-In. *BioOhio Members can save $100! Contact a BioOhio team member for your discount code.
–
FBI Cincinnati Division in coordination with Butler County Sheriff’s Office Bomb Squad, is holding a Chemical Industry Outreach Workshop (CIOW). Who Should Attend: The focus of this CIOW is to conduct and develop liaisons with chemical industry safety/security professionals, chemical industry health and safety experts, other chemical industry representatives, chemical sales (industrial and retail), and academia. The CIOW is part of the FBI’s National Improvised Explosive Familiarization (NIEF) initiative designed to raise awareness of the use of common chemicals to produce improvised explosives. The classroom portion of this training will be held at Butler Tech. The main body of morning briefings will focus on FBI initiatives, capabilities/investigations and the overall chemical threat. After a networking break, FBI Special Agent Bomb Technician will provide a brief on explosives and associated Improvised Explosive Devices (IED’s). The afternoon will consist of a short field trip to the Butler County Bomb Squad explosives range for a live demonstration of various explosives and IED’s; most of which can be mixed using common household chemicals. Please RSVP by 4/21/2022. |
0 events,
|
0 events,
|
0 events,
|
0 events,
|