2024 Annual Conference – Schedule At-A-Glance
Schedule at-a-glance
| 7:30-8:15 | Welcome to the 30th Anniversary OCRA-DG Annual Conference Registration/Pick up Badge & Light Breakfast |
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| 8:15-8:30 | Ceremony and Welcome Address Welcome note by the President of OCRA-DG and Conference Chair |
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| 8:30-9:00 | Opening Plenary: Landscape of Imports & Exports of FDA-Regulated Products | ||
| 9:00-9:15 | Transition Break | ||
| TRACKS | Track A (Pharma/Biologics) |
Track B (Devices/Diagnostics/Combination Product) |
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| 9:15-10:15 | Postmarketing Surveillance Expectations and Compliance | The Role of Real World Evidence in Supporting Medical Device Regulatory Submissions (Global) | |
| 10:15-10:30 | Networking Break with refreshments | ||
| 10:30-11:30 | Gene therapy | European In Vitro Diagnostic Regulation (EU IVDR) | |
| 11:30-12:30 | Lunch | ||
| 12:30-1:30 | Regulatory Compliance Landscape and GMP Surveillance | Computational Modeling and Simulation in Medical Device Submissions | |
| 1:30-1:45 | Networking Break with refreshments | ||
| 1:45-2:45 | FDA Current Regulations of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) | Artificial Intelligence in Medical Devices | |
| 2:45-3:00 | Networking Break with refreshments | ||
| 3:00-4:00 | Quality Management Maturity and Essential Tools to be Audit Ready | Navigate the Recent Updates and Challenges in Combination Products Regulatory Landscape | |
| 4:00-4:15 | Transition Break | ||
| 4:15-4:50 | Closing Plenary: Looking to the Horizon – Innovations in regulatory profession – Reorganization of ORA and Centers taking direct lead in Compliance – How FDA reorganization impacts industry – Global inspection readiness using inspection software with AI |
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| 4:50-5:00 | Closing Remarks OCRA-DG President and Chair | ||
| 5:30-closing | Social Reception – Complimentary Food and Beverages (Open Bar) | ||