November 9-10, 2016

PQRI/USP Workshop on Implementation Status of ICH Q3D Elemental Impurities Requirements – Analytical and Risk Assessment Challenges

October 5-7, 2015

2nd FDA/PQRI Conference on Advancing Product Quality

Full program (PDF)

March 31-April 1, 2015

PQRI/USP Workshop on Elemental Impurity Requirements in a Global Environment – Next Steps?

Program, updated 4/3/15

FDA/PQRI Conference on Evolving Product Quality

Final Program Agenda, updated 10/23/14 »

The PQRI facilitates educational workshops and programming on projects related to the Institute’s vision and mission.

PQRI Workshop on Sample Sizes for Decision Making in New Manufacturing Paradigms – Agenda (PDF)

Coordinated PQRI Workshop with RDD 2010 on Addressing the Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products – Flyer (PDF), Agenda (PDF)

RDD Conference (April 25-29)
PQRI Workshop (April 30)
Both meetings at the Omni Orlando Resort at ChampionsGate, Orlando, Florida
For additional information on both meetings go to http://www.rddonline.com/rdd/rdd.php?id=5&sid=3

Registration Information

RDD/PQRI Speakers Presentations

January 14-15, 2014
PQRI Workshop on Nanomaterial Drug Products
USP Meeting Center
Rockville, MD – Agenda (PDF)

Make your hotel reservation with discounted rate here.* »

December 9-10, 2013: POSTPONED due to inclement weather
Makeup Dates: April 27-28, 2014
Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables
Cosponsored by USP and PQRI
USP Meeting Center
Rockville, MD
December Agenda (PDF) | Makeup April Agenda – Day 2 (PDF)

Poster 1 (PDF)
Poster 2 (PDF)
Poster 3 (PDF)
Poster 4 (PDF)
Poster 5 (PDF)
Poster 6 (PDF)

May 20-21, 2013
USP/PQRI Workshop on Pharmaceutical Packaging: Moisture Permeation and Integrity Testing
USP Meeting Center
Rockville, MD

Mar. 11-13, 2013
PQRI Workshop on the Evaluation of Topical Drug Products—Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies
USP Meeting Center
Rockville, MD – Agenda (PDF)
*Make your hotel reservation with discounted rate here.* »

*Postponed*
PQRI Workshop on Biosimilars – How Close is Close Enough—The workshop is being postponed at this time. More information will follow regarding the rescheduling of the workshop.
USP Meeting Center
Rockville, MD

Sept. 5-6, 2012
PQRI Workshop on Application of IVIVC in Formulation Development
Co-sponsored with AAPS, FDA, FIP, and USP
Bethesda North Marriott
Bethesda, MD – Agenda (PDF)

Feb. 22-23, 2011
PQRI Workshop on Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP)
Bethesda, MD – Agenda (PDF)

Dec. 1-3, 2010
PQRI/FDA Workshop on Process Drift – Agenda (PDF)

Dec. 15-16, 2009
PQRI Conference on Advancing Drug Product Quality and Development – Flyer (PDF), Agenda (PDF),Excellence in Research Awards, Research Award Nomination Form (DOC), Hotel Information (PDF), Rockville, MD

Click on a speaker and/or breakout session’s name within the Agenda PDF in order to view their respective presentations.

Suggest a Workshop
Past Conferences and Workshops

If you are having problems viewing the PDF documents or they open to a blank page, please reference this article for assistance.

Organizational Structure (PDF)

The PQRI Organizational Chart is a graphical representation of PQRI’s hierarchical structure. The chart displays each Technical Committee and its corresponding Working Groups. Information about committee leadership is also highlighted.

Board of Directors

The Board of Directors has authority over the collection and disbursement of funds and the administrative procedures required to ensure the effective operation of the Institute.

Steering Committee

The PQRI Steering Committee has sole authority over all scientific activities undertaken in conjunction with the Institute and is responsible for recommending all Institute funds spent in conjunction with scientific activities, specifically all research done under the auspices of the Institute.

Technical Committees

PQRI consists of three Technical Committees that provide technical and scientific guidance, direction and review for PQRI Working Groups. The Technical Committees consist of scientists and regulatory experts from industry and regulatory agencies, and make technical/scientific recommendations to the Steering Committee.

Working Groups

PQRI currently has several very active Working Groups operating under the guidance of each Technical Committee. These Working Groups consist of scientists from industry, academia and FDA, who generate, evaluate, and discuss information or data, and develop PQRI recommendations, technical reports, and scientific papers.