Skip to main content

PDA Regulatory Conference 2025 Main banner

Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Livestream Agenda

  
    Lunch with the Regulators will not be livestreamed.

Livestream Agenda

Type here to filter the list

Wednesday, September 10, 2025
07:15 - 08:15 ET
Breakfast 3: Building a Strong Quality Culture (Rock Creek A)
Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Breakfast Session

07:15 - 08:15 ET
Breakfast 4: Post-Approval Changes and Lifecycle Management (Rock Creek B/C)
Moderator: Eva M. Urban, MSc (she/her/hers) – Bristol Myers Squibb
Breakfast Session

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) – Eli Lilly and Company
Panelist: Donald B. Ertel, MS, MT (ASCP) (he/him/his) – U.S. FDA
Panelist: Juan Jimenez, JD – U.S. FDA
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