Agenda - Day 2 - Tuesday 16th June

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Biocompatibility Workshop Day - Salon Rome

09:00 - 09:40

Part 1: Opening Remarks & The State Of The Art In Biocompatibility

Gap analysis of existing biological evaluations under the new ISO 10993-1 revision

Workshop Summary: This interactive training will provide an overview of medical device biocompatibility with a focus on entire biological evaluation process from development of a biological evaluation plan through testing and biological evaluation report according to ISO 10993-1:2025 requirements

Beau Rollins - Principal Consultant, Intrinsic Medical Group

09:40 - 10:20

Part 2: Structured Approach To Developing a Biological Evaluation Plan (BEP)

From regulatory intent to practical execution

Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group

10:20 - 11:05

Part 3: Biological Risk Assessment in Practice

Risk identification, justification, and expectations

Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group

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Biocompatibility Workshop Day - Salon Rome

11:35 - 12:20

Part 4: Designing a Defensible Test Strategy Within The BEP

Aligning scientific rationale with ISO 10993 requirements

Beau Rollins - Principal Consultant, Intrinsic Medical Group

12:20 - 12:45

Interactive Session: Activities 1 & 2

12:45 - 13:20

Part 5: Understanding and interpreting test results

Common pitfalls & resolution

Beau Rollins - Principal Consultant, Intrinsic Medical Group

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Biocompatibility Workshop Day - Salon Rome

13:20 - 14:20

Lunch Break

14:20 - 14:35

Part 5: Understanding and interpreting test results

Beau Rollins - Principal Consultant, Intrinsic Medical Group

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Biocompatibility Workshop Day - Salon Rome

14:35 - 15:20

Part 5: Understanding and interpreting test results

Beau Rollins - Principal Consultant, Intrinsic Medical Group

15:20 - 15:35

Part 6: From BEP to BER: translating strategy into conclusions

Toxicological risk assessment (TRA), real-world examples and questions from agencies

Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group

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Biocompatibility Workshop Day - Salon Rome

15:35 - 15:55

Part 6: From BEP to BER: translating strategy into conclusions

Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group

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Biocompatibility Workshop Day - Salon Rome

15:55 - 16:10

Afternoon Break

16:10 - 16:55

Practical Exercises: Activities 3 & 4

16:55 - 17:25

Part 7: The life cycle of a biological evaluation

Change management, lifecycle updates & maintaining compliance

Beau Rollins - Principal Consultant, Intrinsic Medical Group

17:25 - 17:35

Open Q&A + Expert Exchange

Day 2 - Tuesday 16th JuneTuesday, 16 June 2026 - CEST Time Zone

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