Jennifer Ahearn, Vice Chair of the PQRI Steering Committee invites you to register for the 4th FDA/PQRI Conference on Advancing Product Quality!

4th FDA/PQRI Conference on Advancing Product Quality:
Patient Centric Product Design, Drug Development, and Manufacturing
April 9 – 11, 2019
Rockville, MD


New: Call for Poster Abstracts (see below for details)

Dear Colleagues:

On April 9-11, 2019, FDA and PQRI will host the 4th FDA/PQRI Conference on Advancing Product Quality: Patient Centric Product Design, Drug Development, and Manufacturing at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center in Rockville, MD USA.

On-line registration is open. Register before November 1st to receive the early bird rate (save $200). We expect a very good turnout for this Conference, so please register early to save your seat. For a copy of the current draft program and to register, please visit:

The 4th FDA/PQRI Quality Conference will bring together leaders from regulatory agencies, industry, and academia to discuss key, critical topics in drug product quality. Input from attendees will aid in future FDA guidance development.

Following morning plenary sessions on Day 1 and Day 2, attendees will breakout into three themed concurrent tracks:

Track #1: Novel Approaches to Improve Treatment Outcome and Patient Safety
Providing the intended therapeutic effect, in a safe manner, is the centerpiece of a quality drug product. The complexity of novel formulations and modalities increases the needs for robust characterization of such products and integration of knowledge/data to first understand and subsequently project their clinical behavior. Novel characterization methodologies and tools and modeling and simulation approaches will be discussed towards these goals.

Track #2: Emerging Technologies and Patient Centricity in Early Drug Development
Current and future thinking on the role of new/emerging technologies in driving contemporary early development across the broad small-to-large molecule spectrum. Advancing understanding, dialogue and awareness of opportunities to “design in” patient centricity as a core attribute and consideration in early drug development to enhance the overall patient experience.

Track #3: Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products
The rapidly evolving manufacturing methods for gene and cell based therapies and continuous processes require new approaches related to analytics, validation and registration. This Track will explore each of these areas and the evolving expectations.

Day 3 will include a Special Plenary Session with FDA and the introduction of a new FDA initiative (details to come).


FDA/PQRI Conference Organizers are inviting abstract submissions for scientific posters. Individuals and groups interested in presenting posters should submit an informative abstract by November 16, 2018. See Poster Abstract Guidelines for more information.

The Scientific Poster Session will be continuously accessible during Day 1 and Day 2 of the Conference (April 9 and 10). Awards for first, second, and third prize for “best” poster will be awarded on Day 3 (April 11). Attendees at the Conference will vote for the poster awards.


Don’t forget to reserve your room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center. The special Conference room rate will be available until March 19, 2019 or until the group block is sold-out, whichever comes first. To reserve your room on-line, click here: Hotel Reservation.