NanoBCA Recommends: FDA NanoDay Symposium 2022 – October 11th
Posted on September 7th, 2022 in Uncategorized | No Comments »
The NanoBusiness Commercialization Association (NanoBCA) would like to recommend the following:
FDA NanoDay Symposium 2022
October 11, 2022
8:50 AM – 3:10 PM Eastern
This event is free.
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ABOUT THIS EVENT
This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. FDA speakers will present reviewer perspectives on drug development and laboratory efforts to facilitate further understanding of challenges to manufacture products that contain nanomaterials. Two additional speakers will address safety evaluations of foods to contact surfaces that contain nanomaterials and the development of standard materials and methods for nanomaterials.
– FDA will discuss the primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials
– FDA will provide case studies on the development of the COVID mRNA lipid nanoparticle vaccine products
– FDA will present efforts to establish standards and standard methods for monitoring products that contain nanomaterials
TOPICS COVERED
– An overview and discussion of the recently finalized “Guidance to Industry: Drug Products, Including Biological Products, that Contain Nanomaterials”
– A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products
– A nonclinical perspective of developmental challenges of products that contain nanomaterials
– The development of regulatory standards and methods for controlling products that contain nanomaterials
INTENDED AUDIENCE
– Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review
– Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials
– Foreign regulators who review comparable pharmaceutical products that contain nanomaterials
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The NanoBusiness Commercialization Association (NanoBCA) is holding a raffle fundraiser to award scholarships for the future leaders of the Nanotechnology Community.
SCHOLARSHIP FUNDRAISER GOAL $25,000
Raffle tickets $25 each BUY TICKETS
Drawing held on November 1st
50% of the winnings will go to the scholarship fund
50% of the winnings will go to the raffle winner
We hope you join the initiative to fund the next generation of Nanotechnology leaders.
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In addition to recommending events that are relevant to our nanotechnology community, NanoBCA offers our members the opportunity to participate in our monthly webinars. Our monthly webinars address topics involving the relationship between the science of nanotechnology and Environmental, Health & Safety (EHS), US Legislation, Covid-19, Education, Finance, Manufacturing and Foreign Policy.
Our next NanoBCA webinar is scheduled for Wednesday, September 28th at 2PM ET.
ACADEMIC/YOUNG PROFESSIONAL MEMBERSHIP $100
START-UP CORPORATION MEMBERSHIP $1,000
One of the benefits of NanoBCA membership is access to our previous webinars with America’s leading scientists and engineers.
We look forward to continuing our legacy relationships and welcoming a new generation of NanoBCA members.
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Once again, we highly recommend the FDA NanoDay Symposium 2022.