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.