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Clinical Challenges Under the EU MDR

Online Event

With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of Notified Bodies designated under the MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024. NAMSA invites you to join this upcoming webinar as our team of regulatory experts discuss practical insights to address these challenges.

Humanizing Healthcare: Elevating Health Experiences

Online Event

The surge in digital healthcare technologies has reshaped the healthcare experience for consumers. Consumers are looking for more personalized health experiences where they are in control of their health but they are also more aware of the risks and benefits of sharing their data. Now more than ever, it’s important organizations understand how to use technology to deliver value while addressing consumer concerns around data, consent and security.

The Need for Transitional Coverage for Emerging Technologies (TCET)

Online Event

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.

The Conference on Innovations in Climate Resilience

Columbus, OH

The Conference on Innovations in Climate Resilience, presented by Battelle in collaboration with DOE National Laboratories, offers a curated technical program with invited keynote presentations, platform and lightning talks and a poster reception. We’re expecting an audience of government leaders, entrepreneurs and innovators to explore breakthroughs in technology, science, policy and infrastructure that will help mitigate the threats to our environment, health, communities, national security and economic well-being from a changing climate.

2022 Engineering Graduate Student & Postdoc Industry Recruitment Event

Online Event

The Ohio State University and the College of Engineering would like to invite you and your colleagues to join us for the VIRTUAL 2022 Graduate Student & Postdoc Industry Recruitment Event on Tuesday, April 5th! If you are looking to fill internships or entry-level positions with diverse, high-caliber engineers at the M.S., Ph.D., or Postdoctoral levels, then this is the event for you. Come join us!

2022 Engineering Spring Into Your Career Fair

The Ohio State University Columbus

The Engineering Society of Professional Excellence (ESPE) in partnership with Engineering Career Services will host the Spring Into Your Career Fair (IN PERSON) on Wednesday, April 6th 2:00 p.m. – 5:00 p.m. at the Performance Hall in the Ohio Union. The Spring Into Your Career is an excellent opportunity to fill immediate needs within your organization with interested, highly qualified Ohio State engineering and computer science students seeking co-op, internship, and career employment opportunities for summer and fall 2022.

Transitioning from EUA to 510(k) for IVD Products: Planning to Execution

Online 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.

MDMA 2022 Annual Meeting

Washington, DC

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.

Chemical Industry Outreach Workshop Cincinnati

Butler Tech, Liberty Township

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.

Founders Unfiltered: A Conversation with Afif Ghannoum, co-founder of BIOHM Health.

Online Event

Join JumpStart for the next episode of Founders Unfiltered featuring Afif Ghannoum, co-founder of BIOHM Health. Afif, a biotechnology attorney by training, co-founded BIOHM with his father Dr. Mahmoud Ghannoum, a global leader in medical mycology and Case Western Reserve University Professor. The father and son duo launched BIOHM in 2016 to help bring Dr. Ghannoum’s science to consumers, commercializing probiotics and microbiome testing kits to target fungi and bacteria in the digestive tract. JumpStart will talk to Afif about BIOHM’s recent funding round, the results of their groundbreaking clinical trials and his work commercializing healthcare innovation.