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Point-of-Use Instrument Treatment, Time Well Spent!

Online Event

Every regulatory group is in agreement. Cleaning begins at the point-of-use. So why is it so hard to maintain compliance with this very simple and well-known standard? In this webinar, Healthmark Clinical Education Specialist, Malinda Elammari, will attempt to show the how and why of point-of-use cleaning as well as the vital role it plays in patient safety. This presentation will also give strategies for maintaining compliance over the long term. SPD, OR, Endoscopy, & IP professionals, pay attention!

Accelerating Cell & Gene Therapy Careers

Online Event

The Cell & Gene therapy market is poised to undergo significant growth over the next 2-5yrs growing from a $1B market in 2018 to a ~$9B market by 2025. However, we anticipate finding qualified talent will become a critical roadblock to bringing innovative new therapies to market. Kelly Science & Clinical, the 2nd largest Science staffing agency, is taking the lead to address this challenge head-on by hosting the second installment of (Ex)2: The Expert Exchange Series, Accelerating Cell & Gene Therapy Careers. We will bring together well-known industry experts along with our own experts to discuss the growing talent needs and share with candidates insights and job opportunities for them to ride this wave to accelerate their careers in cell & gene therapy.

PharmaLink Conference 2022

Online Event

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering Pharmalink in 2022. At PharmaLink, we work to find solutions that will increase confidence in product quality throughout your products’ life cycle management and global supply chain. We do this by aligning with the strategic priorities of the FDA and industry - and by helping participants create network links to drive compliant innovations. The solutions might not be evident within our companies, or our industry, so we explore beyond our industry - beyond borders and beyond comfort zones.

Fall Income Tax Reduction Seminar Series

Online Event

Northeast Ohio’s Tax Credits Group (TCG), Duffy+Duffy and KIKO Realtors, Auctioneers & Advisors have announced the dates for their annual Fall income tax reduction seminar series, where attendees will learn powerful tax planning tools and strategies to maximize credits and deductions in order to save significant tax dollars for their clients. In this 50-minute session, Tax Credits Group experts will provide attendees with an update on recent legislative, regulatory, and IRS-issued guidance related to both the Research and Development Tax Credit and the Employee Retention Credit. The free, online seminars will be held over 4 separate dates: November 7 & 29 and December 1 & 7.

Introduction to JobsOhio & the Healthcare Sector

Innovate New Albany 8000 Walton Parkway, New Albany

As the private economic development entity for the state of Ohio, JobsOhio has the pleasure of partnering with many great cities and towns to grow our economy. The purpose of this TIGER Talk is to offer the community information about JobsOhio, the Healthcare Sector, and JobsOhio’s programs to support Ohio businesses at varied stages of development.

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.