The FDA is hosting a 2-day hybrid workshop on "Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products".
Date: October 7 - 8, 2024 via Zoom or in person at The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD
Day1: Mon, Oct 7 8:30 AM - 5:35 PM ET
Day2: Tue, Oct 8 8:30 AM - 5:10 PM ET
From the FDA announcement:
"The purpose of this workshop is to engage stakeholders industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for proposed generic peptide and oligonucleotide drug products.
Experts from the FDA, new and generic drug developers, academic institutions, contract research organizations (CROs), consultants and other scientists involved in generic peptide and oligonucleotide drug product development will collaborate to improve our understanding of the role of immunogenicity risk assessment in supporting generic peptide and oligonucleotide drug product development and enhancing the consistency of risk assessment. The workshop will also allow all interested parties to participate in in depth discussions via working sessions to analyze examples."
Details and registration information are available at CDER Event
#fda #Immunogenicity #workshop #peptide #oligonucleotides
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| CDER Event |
| The purpose of this workshop is to engage stakeholders industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for proposed generic peptide and oligonucleotide drug products. |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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