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Preliminary Schedule
Below is our preliminary schedule for The Summit. We're still finalizing a few details, so times and topics may shift slightly before the event.
Day One
Wednesday, November 11
8:00 – 8:30 AM
Registration & Breakfast
8:30 – 8:45 AM
Welcome, Introductions & Ground Rules
8:45 – 9:45 AM
Session 1: FDA's Environmental Monitoring Enforcement
Marianna Dakanali (University of Michigan) · Rick Jahn (GE HealthCare)
9:45 – 10:30 AM
AM Break
10:30 – 11:30 AM
Session 2: Incoming Materials Testing
Robin Cumming (UCSF) · Chris Parr (Pharmalogic)
11:30 AM – 12:45 PM
Lunch
12:45 – 1:45 PM
Session 3: Addressing FDA Inconsistency & Training Level of Reviewers/Inspectors
David Dick (University of Iowa) · Eric Webster (Telix Pharmaceuticals)
1:45 – 2:00 PM
PM Break
2:00 – 3:00 PM
Session 4: Communicating Risk Assessment & Justification with the FDA
Rick Jahn (GE HealthCare) · Cathy S. Cutler (BNL)
3:00 – 3:15 PM
PM Break
3:15 – 4:15 PM
Day 1 Wrap-Up & Preview of Day 2
5:00 – 6:30 PM
Reception at Local Establishment
Day Two
Thursday, November 12
8:00 – 8:30 AM
Breakfast
8:30 – 8:45 AM
Introduction & Preview of Today's Objectives
8:45 – 9:45 AM
Session 5: External Relationships — Effective Cultivation & Communication
Steve Zigler (PETNET) · Adam Rosenberg (Vanderbilt University Medical Center)
9:45 – 10:15 AM
AM Break
10:15 – 11:15 AM
Session 6: Theragnostics / Therapeutics
Cathy S. Cutler (Brookhaven National Laboratory) · Keith Bowen (Eli Lilly and Company)
11:15 AM – 12:15 PM
Prioritization Discussion — align on priority topics across all six sessions
12:15 – 1:15 PM
Lunch
1:15 – 2:15 PM
Next Steps, Project Owners and Timeline
2:15 – 2:30 PM
Closing Remarks