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Navigating the Landscape for Over-the-Counter or Direct-to-Consumer IVD Tests

Online Event

Healthcare diagnostics has seen a significant increase in over-the-counter (OTC) or direct-to-consumer (DTC) testing. A trajectory that was already in the making prior to COVID-19, this area has increased at a faster pace as more consumers are comfortable performing OTC tests at home. This change in consumer expectation, as well as an evolution of global regulatory requirements, has led to increased considerations and requirements by IVD manufacturers to produce robust testing options. Join NAMSA for this webinar as we evaluate those enhanced requirements specifically as they affect human factors and usability engineering to ensure all IVDs are safe and effective for the intended users, uses and use environments. Early understanding of these requirements is crucial and can influence the device display, controls, functions, results interpretations, instructions and countless other design inputs impacting the consumer.

Exhaustive Extractions in E&L Studies – Endpoint Determination Challenges, Expectations and Reality

Online Event

Join NAMSA for this webinar where we will discuss the most common approaches used for determining the exhaustive endpoint, their advantages and disadvantages and their influence on study design and results. We will also outline how regulatory requirements and laboratory execution diverge, as well as other challenges of an E&L study that are influenced by a lack of standardized procedures (e.g. mass balance, toxicological assessment).

How to Optimize Your R&D Tax Credits with ADP

Online Event

Companies performing qualified R&D activities can be rewarded by lucrative federal and state tax incentives in the form of R&D tax credits, even if their efforts were not successful. This is particularly true for small-to-midsized BIO and state life science association members. BIO recently partnered with ADP to provide discounted R&D tax credit services to life science companies. Join us for a complimentary webinar to learn how to maximize this new BIO-ADP tax credit offering.

Biosortia Microbiomics presenting, Directly Obtaining Signaling Small Molecules Industrial-Scale Microbiome Mining (in-person/virtual)

Online Event

Presented By: Ross Youngs – Founder/CEO of Biosortia Microbiomics. Both online and in-person sessions will be offered for this event. For over 70 years, the quest to obtain the metabolites or small molecules in unculturable microbes has been a goal of many researchers seeking the best starting points in drug and life science discovery. With only 1% of microbes growing in a culture or bioreactor, the ability to directly obtain has been stymied by nature. The pivot to indirect methods has hit the firewall of nature’s complexity leading mostly to irrelevant and incomplete results. Learn how industrial-scale microbiome mining will open up direct access to these sought-after small molecules from potentially 100% and how this new source will impact therapeutics, agriculture, sustainability, cosmetics, and the entire range of life science discoveries.

A Practical Guide to Writing Summaries of Safety and Clinical Performance

Online Event

When it comes to medical documentation, it is important for the inclusion of complex technical information to be easily comprehended by patients or other lay-persons, who are often the intended audience. This is especially true for EU Medical Device Regulation (MDR) Summaries of Safety and Clinical Performance (SSCPs), and is considered a key attribute. Join NAMSA for an engaging and practical webinar, led by one of our former Notified Body auditors, where we will review MDR SSCPs from the Notified Body perspective with a focus on demonstrating how to write clear, concise and informative SSCPs.

G2G’s Monthly Non-Dilutive Funding: GBG Reporting Service Webinar

Unlock Non-Dilutive Funding! Ohio Life Sciences Member Benefit
Every 3rd Thursday, G2G - Innovative Government Affairs Consulting hosts a FREE webinar for members to learn about grant opportunities in life sciences. At 12:30 pm EDT (premium service and consultation for OLS members, G2G clients and GBG customers).