
Join us for another premier event, an inspiring symposium focused on best practices, practical insights, an meaningful networking opportunities you won’t want to miss.
Date: Oct 28, 2025, Tuesday
Time: 12:30 – 6:30 pm PT
Location: University Club: Secret, Sophisticated Irvine, CA Wedding Venue
801 E Peltason Dr, Irvine, CA 92617
Dinner: Included
Price: $75 non-member, $50 member and early bird (end Sep 1)
Parking: Free
| 12:00-1:00 | Registration | |
| Pharma | Device | |
| 1:00-1:45 | Speaker: Peder Seglund, PhD Topic: Increasing Efficiencies and Reducing Costs by Implementing Artificial Intelligence and Outsourcing for Regulatory Affairs and Pharmacovigilance |
Speaker: Heinz Steneberg Topic: EUDAMED updates |
| 1:45-2:00 | Break | |
| 2:00-2:45 | Speaker: Natalie Pripuzova,PhD Topic: Navigating Regulatory Expectations and the Complexity of Control Strategy in Allogeneic Cell and Gene Therapies |
Speaker: Bryant Foster Topic: Finding the Right Dose of Human Factors for Your Medical Device or Combination Product |
| 2:45-3:00 | Break | |
| 3:00-3:45 | Plenary Session Topic: Preparing for Inspections (FDB) |
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| 3:45-4:00 | Break | |
| 4:00-4:45 | Speaker:Jon Mann Topic: Compliance Circling Calibrations |
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| 4:45-7:00 | Dinner | |