M-CERSI in-person workshop on PBBM: Aug 29-31 [Conferences / Workshops]

posted by SMA – Europe, 2023-07-17 16:53 (315 d 05:11 ago) – Posting: # 23673
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The FDA/M-CERSI in-person workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Scientific Practices to Drive Drug Product Quality: Latest Regulatory and Industry Perspectives”, which will be held Aug 29-31 2023 at Universities at Shady Grove (Rockville, MD). The purpose is to discuss the best scientific practices for developing PBBM models for orally administered, systemically active drug products and how these models can be leveraged for streamlining pharmaceutical drug product development, and supporting manufacturing changes and controls.

Real PBBM case studies for oral drug products submitted as part of global marketing applications will be discussed by FDA, EMA, Health Canada, ANVISA, MHRA and PMDA.

Breakout topics include:Registration closes Aug 17. Registration available here

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