The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda
The PDA Regulatory Conference is a little different this year. While the U.S. Food and Drug Administration (FDA) is not an official cosponsor, the event still boasts wide Agency support with more than 30 experts from the FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Vetinary Medicine (CVM), and Office of Inspections and Investigations (OII), appearing on the podium as moderators, IG co-facilitators, speakers and panelists. The theme of this year’s event is “Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle.”
Returning to Washington, DC for the 34th year, PDA's September regulatory conference remains the pharmaceutical industry’s most trusted forum for open, informed dialogue between global regulators and industry professionals. For more than three decades, this event has delivered the insights needed to strengthen compliance, advance quality systems and protect patients worldwide.
Whether joining in person or via livestream, attendees will gain valuable insight from the FDA in the second plenary session of the first day: Current GMP Compliance Trends and Topics. Here, Francis Godwin, Dir. CDER Ofc. of Manufacturing Quality and Jonathan Swoboda, Consumer Safety Officer, CBER Ofc. of Compliance and Biologics Quality, will dig deeply into the latest compliance trends. They will be joined by Jeffrey Meng, Associate Dir., Emerging Technologies and Advanced Manufacturing, OII Medical Products Inspectorate, and Dillard Woody, Branch Chief, CVM Ofc. of Surveillance and Compliance.
Following Plenary 2, FDA officials will appear as speakers and panelists in most of the breakout sessions. On the third day, another plenary session is dedicated to important presentations from experts from the FDA. Plenary 4: Regulatory Priorities and Enforcement Outlook features Melissa Mendoza, Dir., CBER Ofc. of Compliance and Biologics Quality, Jill Furman, Dir., CDER Ofc. of Compliance, Cindy Burnsteel, Dep. Dir. Drugs and Devices, CVM Ofc. of Surveillance and Compliance, and Ivy Sweeney, Acting Dir., Ofc. of Human and Animal Drug Inspectorate, OII.
This year’s event features a special preconference roundtable hosted by PDA’s Capital Area Chapter on Sunday, 07 Sep., on the FDA Complete Response Letters (CRLs). Former Acting Dir., FDA CDER Ofc. of Compliance, Thomas Cosgrove, will examine the increased frequency and significance of CRLs, providing a timely overview of the challenges they present and the implications for regulatory strategy and operational readiness. All roundtable registration fees will be donated to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of pharma leaders.
It is not too late to register for the PDA Regulatory Conference 2025—join us in DC or via livestream! Click here for the conference site.