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July 2020

Transitioning from EUA to 510(k) Clearance for IVD Products, What to Expect, a NAMSA webinar

July 16 @ 11:00 am - 12:00 pm
Online Event OH United States

In Vitro Diagnostic (IVD) products go through a stringent 510(k) evaluation process in order to be certified and placed in the U.S. However, as a result of the ongoing COVID-19 Pandemic, several assays and analyzers have entered the market through the Emergency Use Authorization (EUA) pathway to fast track approval. While EUA provides an opportunity for IVD manufacturers, these IVDs will eventually have to comply with U.S. FDA 510(k) requirements to remain on the market. Join BioOhio member NAMSA for…

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Xavier Health Virtual 510(k) Workshop

July 22 - July 23
Online Event OH United States

Join Xavier Health on July 22 and 23 for the virtual 510(k) Workshop. The virtual event will cover the following topics: History of 510(k)s as well as touching on the other approval pathways to put 510(k) into context Risk Management and Design Controls IDE and clinical data for 510(k) Modifications Document Pre-Subs Who to engage across the TPLC to ensure al the studies, data and information are set for filing – how to mobilize an effective process in your company The…

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NAMSA & RAPS present Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

July 29 @ 10:00 am - 11:00 am
Online Event OH United States

Regulatory affairs professionals must have both a solid foundation surrounding regulatory strategy and an in-depth understanding of how this plan links to the overall product development strategy to achieve efficient, cost-effective development outcomes, and commercialization success. Whether navigating a new regulatory pathway, understanding how to secure clinical data to achieve successful commercial outcomes or ensuring reimbursement strategies are coordinated with regulatory strategy throughout the planning process, it is essential all stakeholders to take steps to secure broader market success for…

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September 2020

2020 RAPS Convergence

September 12 - September 15
Henry B. González Convention Center, 900 E Market St.
San Antonio, TX 78205 United States
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Join the Regulatory Affairs Professionals Society (RAPS) on September 12-15 in San Antonio, Texas for the 2020 RAPS Convergence. RAPS Convergence is focused exclusively on regulatory for the healthcare products industry. Covering topics that find new ways to examine and solve regulatory challenges, Convergence includes expert-led educational sessions, pre-conference workshops on the hottest topics in the field and networking with the best regulatory professionals in the world. In 2020, break the regulatory mold with RAPS. Click here to learn more and…

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October 2020

Xavier Health Combination Products Summit 2020

October 27 - October 29
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Save the date for the 2020 Combination Products Summit, presented by Xavier Health. Summit Agenda Highlights 2019 Actionable insights on these topics and more: Successful Practices and Challenges for Supplier Partnering EU Medical Device Regulation – Preparing for Implementation Connected Digital Technologies - Understanding the Impact of the Evolving Regulatory Landscape Post Approval Changes: CH Q12 and Latest FDA Guidance Post Market Safety Reporting Click here to learn more.

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