📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG)

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Registration has opened for the ’ Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products

Date and Time: November 6 & 7
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)

Several of the Nitrosamines Exchange community will be in-person presenting at this event.

The workshop’s focus is to review the current research and recommendations on confirmatory NDSRI formation, safety testing methods for NDSRIs and recommended acceptable intake limits for NDSRIs based on predicted carcinogenic potency and compound-specific data or read-across analysis. The workshop will also discuss strategies to mitigate the risk of NDSRI formation. Another key focus of the workshop is to provide updates on the guidance in assessing formulation stability and recommendations for bioequivalence approaches when drug developers are considering reformulation. The speakers and panelists will also discuss the regulatory approaches for navigating the implemented changes and share their regulatory experiences in pre- and post-approval changes in ANDA/NDA submissions and supplements illustrated with relevant case studies.

Registration page: https://www.complexgenerics.org/education-training/updates-on-approaches-to-acceptable-intakes-of-nitrosamine-drug-substance-related-impurities-ndsris-and-bioequivalence-assessment-for-reformulated-drug-products/

Program includes:

  • Safety & Risk Assessment Methods and Recommendations for Acceptable Intake Limit
  • Risk Factors of Formation of NDSRIs and Mitigation Strategies
  • Update on the Policy Guidance and Recommendation in Assessing Formulation Stability and Bioequivalence Approaches

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