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Day 2 - Tuesday 16th June - CEST Time Zone
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Day 2 - Tuesday 16th June - CEST Time Zone
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Roundtables - Day 2
14:30 - 15:20
Roundtables - Rotation 1
| Table 1: MDR | Question Circle | Table 5: SaMD & AI | Question Circle |
| Table 2: MDR | Tools and Technologies To Simplify Submissions | Table 6: SaMD & AI | Resourcing and Expertise Gaps |
| Table 3: IVDR | Question Circle | Table 7: Biocompatibility Workshop | Question Circle |
| Table 4: IVDR | Clinical Data and Performance Studies | Table 8: Biocompatibility Workshop | Question Circle |
- Mahua Yasmin - Senior Regulatory Affairs Specialist, Johnson & Johnson
- Beau Rollins - Head of Biocompatibility, ConvaTec
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group
15:20 - 15:40
Refreshment Break
15:40 - 16:30
Roundtables - Rotation 2
| Table 1: MDR | Question Circle | Table 5: SaMD & AI | Question Circle |
| Table 2: MDR | EU Biotech Act - going from policy to practice | Table 6: SaMD & AI | Future-proofing SaMD products |
| Table 3: IVDR | Question Circle | Table 7: Biocompatibility Workshop | Question Circle |
| Table 4: IVDR | Navigating the notified body bottleneck | Table 8: Biocompatibility Workshop | Question Circle |
- Mahua Yasmin - Senior Regulatory Affairs Specialist, Johnson & Johnson
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group
- Beau Rollins - Head of Biocompatibility, ConvaTec
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