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
8:15-8:30 Ceremony and Welcome Address
Welcome note by the President of OCRA-DG and Conference Chair
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)

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
4:50-5:00 Closing Remarks OCRA-DG President and Chair
5:30-closing Social Reception – Complimentary Food and Beverages (Open Bar)