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Day Two – 17 June 2025 - CEST Time Zone
- Beau Rollins - Global Director, Quality Services, ConvaTec
The beginnings of the BE
Intent of a BE
Definitions and foundations
Standard intent vs regulator interpretation
Utilizing Design inputs
How to properly define intended use and device categorization
Literature search
How to reference competitive devices
Clinical evaluation data integration
Group divisions and BEP creation exercise
E&L test requirements and set up
Correct Dose Base Threshold (DBT) for device
Calculation of Analytical Evaluation Threshold (AET)
Method Uncertainty Factor (UF), sensitivity, solvent selection
Applying to intended use and materials
Traditional endpoint tests and critical factors
In-vitro vs In-vivo
Extraction time, temp, and ratios.
Determining gaps from E&L, literature, etc to determine appropriate endpoint test
Group division and BEP completion
- Beau Rollins - Global Director, Quality Services, ConvaTec
E&L test reports and applying AET for compound analysis
Acceptance criteria for traditional endpoint tests
Common deviations
What to do if you fail
Addition of all test data and results determination
Gap assessment to data, deviations, historical testing
Developing a final conclusion
Group division and BER completion
Evaluating compounds
NOAEL/LOAEL
Cramer categorization
Unknown determination
MOS calculation per ISO 10993-17
Group division and Tox assessment