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Livestream Agenda

  
    Lunch with the Regulators will not be livestreamed.

Livestream Agenda

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Wednesday, September 10, 2025
08:30 - 10:30 ET
P4: Agency Updates: Regulatory Priorities and Enforcement Outlook (Potomac Ballroom)
Moderator: Karyn M. Campbell – AbbVie Inc.
Plenary

11:00 - 12:15 ET
P5: Sustainable CGMP Remediation Plans and Communication: FDA Updates (Potomac Ballroom)
Moderator: Paul Z. Balcer (he/him/his) – U.S. FDA
Plenary

12:30 - 13:45 ET
Lunch with the Regulators (Rock Creek Ballroom)
Moderator: Janeen Skutnik-Wilkinson (she/her/hers) – Moderna
Panelist: Donald B. Ertel, MS, MT (ASCP) (he/him/his) – U.S. FDA
Panelist: Juan Jimenez, JD – U.S. Food and Drug Administration, CVM, CGMP Compliance
Panelist: Jeffrey D. Meng, MSE – U.S. FDA
Panelist: Carmelo Rosa, PsyD – U.S. FDA
Panelist: Derek S. Smith, PhD – U.S. FDA

14:00 - 15:30 ET
P6: The “Q” Also Applies to “U” (Potomac Ballroom)
Moderator: Irving Ford, MSc (he/him/his) – Quality Leader
Plenary