Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products Date and Time: October 7, 8:30 am – 5:35 pm,

Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products Date and Time: October 7, 8:30 am – 5:35 pm, October 8, 8:30 am – 5:10 pm https://www.complexgenerics.org/education-training/scientific-and-regulatory-considerations-for-assessment-of-immunogenicity-risk-for-generic-peptide-and-oligonucleotide-drug-products/?utm_medium=email&utm_source=govdelivery Join industry, academic, and FDA experts for a dynamic workshop on addressing the scientific and regulatory challenges associated with immunogenicity risk assessment for generic peptide and oligonucleotide drug products. Over two days, we'll delve into best practices, case studies, and interactive discussions to enhance our understanding of immunogenicity risk assessment and its critical role in supporting generic peptide and oligonucleotide drug product development and enhancing the consistency of risk assessment. Day 1: Explore cutting-edge approaches to assess immunogenicity risk in synthetic generic peptide drug products, including in silico and in vitro assays, MHC binding, and T cell responses. Plus, learn about innate immune response modulating impurities and their impact. Day 2: Discover how these methods may inform immunogenicity risk assessment for recombinant peptide and generic oligonucleotide drug products. Hear from FDA, academic, and industry experts on strategies and potential pitfalls.