AN IN-PERSON ONLY EVENT – March 20-21, 2025
Registration will open soon. Save the Dates!
FDA and PQRI are hosting an in-person only Exclusive Face-to-Face Workshop with Senior-Level FDA Experts: ANDA Quality with CDER’s Office of Pharmaceutical Quality on March 20-21, 2025 at the Bethesda Marriott (5151 Pooks Hill Road, Bethesda, MD).
WORKSHOP OBJECTIVE
This FDA/PQRI Workshop will bring together experts from industry and senior leaders from CDER’s Office of Pharmaceutical Quality (OPQ) for interactive discussions on critical topics related to generic drug manufacturing and quality.
Attendees of this in-person only workshop can expect live educational presentations from senior, highly experienced regulatory experts on quality topics across the generic drug lifecycle. These focused presentations will cover topics including expectations for applicants of generic drug products, common pitfalls and CMC issues for generic drug manufacturers, and the policy landscape for generic drugs.
This workshop will also provide attendees with interactive discussions with OPQ senior-level experts and leaders on real-world issues related to generic drugs. These live, in-person, interactive sessions between FDA experts and workshop participants will offer a unique opportunity for focused interactions on generic drugs.
PQRI and FDA invite regulatory affairs, CMC, and quality assurance specialists from generic drug manufacturers to join experts and leaders from CDER’s OPQ in Rockville, Maryland for this rare opportunity. Only select recordings of the live presentations may be made available for the public after the workshop. In-person attendance will contribute to strengthening the global commitment to pharmaceutical quality.
DATES
Thursday – Friday, March 20-21, 2025
IN-PERSON EVENT
This workshop will be in-person only. Only select recordings of the live presentations may be made available for the public after the workshop.
WORKSHOP MATERIALS
A Workshop Save the Date brochure is available to share with interested colleagues. Download a copy HERE.
A draft Workshop Program will be available shortly.
REGISTRATION
Registration will open soon.
REFUNDS AND SUBSTITUTION POLICY
If you are unable to attend the Workshop, you may substitute a colleague to take your place at no extra charge. However, if sending a replacement is not possible, refunds will only be processed with 30 days’ written notice and subject to a $50.00 processing fee.
WORKSHOP LOCATION
Bethesda (Pooks Hill) Marriott
5151 Pooks Hill Road, Bethesda, MD 20814
Visit the link above for information on how to get to the Bethesda Marriott.
HOTEL RESERVATIONS
Room block information will be provided once registration opens.
QUESTIONS
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.