The Center for Research on Complex Generics (CRCG) hosts a selection of educational events and workshops throughout the year.
Upcoming events are listed below. Additionally, individuals who are interested in staying up-to-date on CRCG news and activities can subscribe to our mailing list here and be among the first to know when new updates/events are announced.
Upcoming Events:
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Oct. 12, 2023 |
Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development The purpose of this one day workshop is to discuss the challenges, experiences, and advances for the development of oral PBPK modeling to support the establishment of bio-predictive in vitro testing (e.g., dissolution) and to address risks associated with the extrapolation of bioequivalence in various contexts, such as from a fasting to a fed state, from subjects with normal to elevated gastric pH, from a biopharmaceutics classification system (BCS)-based biowaiver, and from other risk-based bioequivalence assessments for oral products. |
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Dec. 7 - 8, 2023 |
Characterization of Complex Excipients and Formulations The purpose of this workshop is to discuss the scientific principles and newly developed analytical methods to support characterizations of complex excipients (e.g., biodegradable polymers vs. nonbiodegradable polymers) and related complex formulations (e.g., ophthalmic, injectable, implantable, and inserted products). |
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Mar. 14-15, 2024 |
Drug-Device Combination Products: Updates and Challenges in Demonstrating Generic Substitutability The purpose of this two-day workshop is to share information with the generic drug industry that may inform drug-device combination product (DDCP) development and to provide a forum to identify and discuss generic DDCP development challenges and explore potential solutions. Insights from GDUFA-funded research results will be discussed, along with FDA guidance recommendations for generic DDCP development. Experts in device user interface assessment, human factors, biostatistics, device quality assessment, and device evaluation will review the current scientific thinking on these topics and contribute to discussions about how best to address challenges and overcome obstacles in the generic DDCP space. |
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May 2, 2024 |
Considerations and Potential Regulatory Applications for a Model Master File The purpose of this workshop is to engage stakeholders in a discussion on the concept, scope, and regulatory application of a Model Master File (MMF), a framework aimed at model-sharing and communication between model developers, industry and FDA. The workshop will discuss challenging aspects of MMF development and implementation. The main objective of the workshop is to facilitate the incorporation and efficient assessment of modeling and simulation evidence in regulatory submissions through coordination and collaboration between the FDA, new and generic drug developers, academic institutions, contract research organizations, consultants and others involved in drug product development. The information exchange and discussions during the workshop will allow for a shared understanding of the role of a MMF in advancing drug product development, enhancing regulatory consistency and efficiency, and streamlining drug product approval. |
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Oct. 7-8, 2024 |
Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products: Present State and Future Directions The use of non-clinical comparative immunogenicity risk assessment for generic peptide and oligonucleotide drug products is gaining momentum as it may facilitate their approval without the need for costly studies. However, the implementation of such an approach requires that the associated assays be suitable for their intended purpose and reproducible. The workshop discussions will focus on recent advances in this field and the remaining hurdles that need to be addressed to help the field move forward in a manner that supports public health. |
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Nov. 7, 2024 |
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products The purpose of this workshop is to review the current research and recommendations on methods for confirmatory testing of 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 NDSRIs formation. Another key focus of the workshop is to provide an update on FDA policy and guidance in assessing formulation stability, and recommendations for bioequivalence approaches when drug developers are considering reformulation. |
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Dec. 4-5, 2024 |
Navigating the Transition to Low Global Warming Potential Propellants The transition of metered dose inhaler (MDI) drug products from hydrofluoroalkane (HFA) propellants to new low global warming potential (LGWP) propellants raises potential scientific and regulatory challenges for both new drug and generic MDIs. This two-day workshop will engage subject matter experts from academia, new and generic drug industries, and the FDA to discuss the current status, challenges, development programs, manufacture, and regulatory considerations for both new and generic MDIs with LGWP propellants. |
