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PDA/FDA JRC Sessions to Include Irish, UK Regulators

Jul 09, 2018

Two international regulators have been confirmed to speak at the 2018 PDA/FDA Joint Regulatory Conference in September.

John Lynch, Director of Compliance, Irish Health Products Regulatory Authority (HPRA), will deliver a presentation in the second plenary, “The Evolving Regulatory Landscape,” on the first day of the conference, Sept. 24, at 11:15 a.m. The session will cover major U.S. and European regulatory initiatives including the U.S. FDA program alignment, organizational changes, key inspectional priorities, the impact of BREXIT, the Mutual Recognition Agreement (MRA) and PIC/S collaboration.

Lynch will also serve as a panelist in the breakout session, “A2: Aging Facilities and Quality Risk Management,” that same day at 5 p.m.

Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement and Standards Division, UK MHRA, will speak in the session “B1: Aseptic Processing/Annex 1.” Her presentation, “EU Regulatory Perspective on Aseptic Processing/Annex 1,” is scheduled for 1:45 p.m. on Sept. 24.

In addition, 25 FDA speakers have been confirmed, with more to come. Continue to check the conference website for updates as new speakers are added to the agenda.


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