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Virtual Event Virtual Event

FDA NanoDay Symposium 2022

October 11

Virtual Event Virtual Event

The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event 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.

Highlighted topic areas include:

  • Primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials
  • Development and Characterization of Generic Drug Products Containing Nanomaterials
  • Considerations for the Quality, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines
  • Case studies on the development of the COVID mRNA lipid nanoparticle vaccine products
  • Future of Continuous Manufacturing of Drug Products Containing Nanomaterials
  • Efforts to establish standards and standard methods for monitoring 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
  • Safety Evaluation of Food Contact Substances Containing Nanomaterials

The intended audience includes: 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; and foreign regulators who review comparable pharmaceutical products that contain nanomaterials.

Please visit the FDA’s NanoDay Symposium 2022 website for more information.

FDA RESOURCES

Details

Date:
October 11
Event Categories:
,
Website:
https://bit.ly/3Ur4Kzd

Organizer

Food and Drug Administration (FDA)
View Organizer Website