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PBBM Report Template: Considerations for Improved Quality in View of Regulatory Submissions

Virtual Event Virtual Event

Sponsored by the Regulatory Advisory Committee Pharmaceutical innovators and generic companies employ Physiologically Based Biopharmaceutics Models (PBBMs) to inform drug product development and may be able to waive clinical pharmacokinetic studies for changes occurring both before and after product approval. The 2023 M-CERSI workshop titled "PBBM Best Practices for Drug Product Quality: Regulatory and Industry […]

Current Industry Practices on Immunogenicity Risk Assessment and Data Analysis

Virtual Event Virtual Event

Presented by the Immunogenicity Working Group Sponsored by the Clinical Pharmacology Leadership Group The Immunogenicity Working Group at IQ Consortium conducted an industry-wide survey with close to 100 molecules with different modalities at different stages of drug development. The objective of this two-part webinar series is to (1) understand the immunogenicity risk assessment and (2) […]

Making Bitter Medicines Better for Everyone

Virtual Event Virtual Event

Presented by the Pediatric Working Group Sponsored by the Drug Product Leadership Group People vary widely in how bitter they perceive medicines to be, which can impact how easily they take them. A global study from the Monell Chemical Senses Center found that genetic ancestry influences how bitter certain medicines taste and how well sweeteners […]