November 14 - 16, 2023
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesotakeyboard_arrow_right
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DAY ONE
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DAY ONE
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Biological Evaluation Execution & Authorship Training Workshop
9:00am - 9:05am
Chairperson’s Opening Remarks
- Beau Rollins - Director, Quality Services, ConvaTec
9:05am - 10:35am
Foundations to Biological Evaluations
- The beginnings of the BE
- Intent of a BE
- Definitions and foundations
- Standard intent vs regulator interpretation
10:35am - 11:05am
Networking Break
11:05am - 11:50am
Process in Creating a Biological Evaluation Plan
- Utilizing Design inputs
- How to properly define intended use and devicecategorization
- 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
11:50am - 12:35pm
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
- Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
12:35pm - 1:35pm
Networking Lunch
1:35pm - 1:40pm
Chairperson’s Afternoon Remarks
- Beau Rollins - Director, Quality Services, ConvaTec
1:40pm - 2:25pm
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
- Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
2:25pm - 3:10pm
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
3:10pm - 3:40pm
Networking Break
3:40pm - 4:25pm
Toxicology Section
- Evaluating compounds
- NOAEL/LOAEL
- Cramer categorization
- Unknown determination
- MOS calculation per ISO 10993-17
- Group division and Tox assessment
- Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
4:25pm - 4:55pm
Life of the Biological Evaluation
- Living document
- Requirements around accuracy
- CCR Impacts and device evolution
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