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Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Biocompatibility Workshop: Biological Evaluation Execution & Authorship Training
09:00 - 09:10
Chairperson’s Opening Remarks: Biocompatibility Workshop
- Beau Rollins - Director, Quality Services, ConvaTec
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
09:10 - 10:40
I: Foundations to Biological Evaluations
- The beginnings of the BE
- Intent of a BE
- Definitions and foundations
- Standard intent vs regulator interpretation
- Beau Rollins - Director, Quality Services, ConvaTec
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Biocompatibility Workshop: Biological Evaluation Execution & Authorship Training
11:10 - 11:55
II: Process in creating a Biological Evaluation Plan
- 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
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
11:55 - 12:40
III: Test design for BEP
- 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
- Crystal D'Silva - Senior Manager, Pre-Clinical Toxicology, Baxter
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Biocompatibility Workshop: Biological Evaluation Execution & Authorship Training
14:10 - 14:15
Chairperson’s Afternoon Remarks: Biocompatibility Workshop
- Beau Rollins - Director, Quality Services, ConvaTec
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
14:15 - 15:00
IV: Understanding and interpreting test results
- E&L test reports and applying AET for compound analysis
- Acceptance criteria for traditional endpoint tests
- Common deviations
- What to do if you fail
- Beau Rollins - Director, Quality Services, ConvaTec
15:00 - 15:45
V:Transitioning into a Biological Evaluation Report
- Addition of all test data and results determination
- Gap assessment to data, deviations, historical testing
- Developing a final conclusion
- Group division and BER completion
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
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Biocompatibility Workshop: Biological Evaluation Execution & Authorship Training
16:15 - 16:45
VI: Toxicology Section
- Evaluating compounds
- NOAEL/LOAEL
- Cramer categorization
- Unknown determination
- MOS calculation per ISO 10993-17
- Group division and Tox assessment
- Ron Brown - Toxicologist, Risk Science Consortium
16:45 - 17:50
VII: Life of the Biological Evaluation
- Beau Rollins - Director, Quality Services, ConvaTec
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