The CMC Side of Bioequivalence MasterClass - EU edition

This two-day online Masterclass translates essential bioequivalence concepts into practical CMC and QC applications. It will help analytical, formulation, dissolution and regulatory professionals understand how the evidences fits together.

02-03 November, 2026, Virtual
Time Zone: UTC/GMT+1 /CET

Overview

For many CMC professionals, bioequivalence remains an abstract concept. The BE study is often viewed as a clinical milestone, while formulation development, dissolution testing, specifications and stability are managed as separate CMC activities. The final BE report may therefore be reviewed only for whether the product passed or failed, without fully understanding how the outcome relates to product development and lifecycle control.

However, bioequivalence is not limited to the clinical study. Drug substance properties, formulation composition, manufacturing variables and in vitro release can all influence the performance of the product administered in the BE study. The resulting evidence may, in turn, inform comparative dissolution, additional-strength or BCS-based biowaiver strategies, the selection of the QC dissolution method and the justfication of dissolution specifications.

The challenge is to understand these connections without overinterpreting what the data can establish.

A passing BE study does not automatically validate a QC dissolution method or specification. A failed BE study does not automatically mean that dissolution was responsible. Similarly, a difference observed between dissolution profiles does not necessarily translate into a meaningful difference in vivo.

This two-day online Masterclass translates essential bioequivalence concepts into practical CMC and QC applications. It will help analytical, formulation, dissolution and regulatory professionals understand how the following evidence fits together:


Drug and formulation a.ributesIn vitro performanceIn-vivo exposureQC methodSpecificationLifecycle control.

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WHO SHOULD ATTEND

-Analytical Development
-Dissolution Method Development
-Formulation Development
-Biopharmaceutics
-Regulatory CMC
-Quality Control and Quality Assurance
-Generic Product Development
-Technology Transfer and Scale-Up
-Product Lifecycle Management
-Pharmaceutical R&D Leadership