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Combination Products Summit 2022

Sonesta Columbus 33 East Nationwide Blvd., Columbus

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 the Combination Products Summit. The AFDO/RAPS Healthcare Products Collaborative combination products community continues to be led by top FDA officials and worldwide industry leaders who built the framework for the regulatory landscape of combination products. This global community drives innovation and navigates the complexities specific to the world of combination products, resulting in the delivery of safe, effective, and high-quality products to the patients who need them.

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.

Walsh University’s Celebration of Science & Technology for the Workforce

Walsh University, North Canton, OH

Walsh University is hosting the annual Science and Technology Business Luncheon on Nov 16, 2022. Keynote speaker, Dr. Jason Kalirai, leads the management and oversight of NASA missions at Johns Hopkins APL, including the Double Asteroid Redirection Test (DART). Please come to celebrate the advancement of Science and Technology in the modern-day workforce.

BioOhio Press Conference in the Ohio Statehouse Atrium

The Ohio Statehouse 1 Capitol Square, Columbus

Join us for an exciting announcement about the organization's next evolution. Ohio’s life sciences industry is on the precipice of a generational opportunity to deliver on the promise of economic advancement and well-being for our state’s residents, and accelerate Ohio’s national leadership in this arena. Join life sciences industry leaders and elected officials for a special event on November 17th. You’ll learn about our next evolution in advancing innovation and advocating for the common interests across Ohio’s life sciences community. This includes a new, cross-sector effort to accelerate workforce development that will be a central fuel for progress, today and for the future. Limited space available – RSVP today to secure your spot! There will be time for networking after the presentation concludes.

Ohio Chamber Healthcare Transformation Summit

Sheraton Columbus Hotel at Capitol Square 75 E State St, Columbus

The Ohio Chamber is holding its inaugural Healthcare Transformation Summit. The summit will bring together stakeholders across the healthcare industry to discuss current challenges, successes, and innovations for tomorrow that will transform healthcare services in order to create a system that is less costly and produces better outcomes for Ohioans. The Summit includes keynote speakers and 17 different panel discussions including topics on access and affordability, workforce development, price transparency, infant mortality and behavioral health. This is a one-day event, with registration opening at 8:30 a.m., the summit starting at 9:30 a.m. and the event ending at 4:00 p.m. BioOhio will be participating in the panel on Workforce Development in Healthcare.

Central Ohio Life Sciences Networking Event & Workforce Discussion

Dupler Office, Columbus, Ohio OH

Ohio Life Sciences has relaunched with a focus on advancing innovation and advocating for the common interests across Ohio’s life sciences community. This includes a new, cross-sector effort to accelerate workforce development that will be a central fuel for progress, today and for the future. OLS is excited to convene our regional life sciences communities across the state and continue to share our mission and build member investor engagement. During this networking event, we will facilitate open dialogue and brainstorming on workforce development opportunities across the state, as well as ways you can get involved to unify industry and education to grow Ohio's life sciences workforce. This FREE event will be hosted by OLS member Dupler Office. Drinks and appetizers will be provided.

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).

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.

Nationwide Children’s Hospital 2023 Technology Showcase

The Blackwell Inn 2110 Tuttle Park Place, Columbus

Join The Office of Technology Commercialization at Nationwide Children's Hospital for presentations about new and impactful technologies emerging through research and innovation at Nationwide Children’s Hospital, an update by our licensee Sarepta Therapeutics, and a keynote presentation on the role of the U.S. Food and Drug Administration in accelerating gene and cell therapy innovation to benefit patients. In-person seating is limited.

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.