Parenteral Drug Association

  


Product Quality Research Institute (PQRI)

The Product Quality Research Institute (PQRI) is a collaborative process involving FDA's Center for Drug Evaluation and Research (CDER), industry, and academia. The mission of PQRI is to conduct research to generate scientific information to support regulatory policy. This initiative helps to identify the types of product quality information that should be submitted in a regulatory filing to CDER. PQRI was incorporated in 1999 as a non-profit. Below are the Founding and New Member Organizations that guide PQRI:

Founding Member Organizations:
American Association of Pharmaceutical Scientists (AAPS)
Consumer Healthcare Products Association (CHPA)
PDA—An International Association for Pharmaceutical and Biopharmaceutical Science and Technology
Pharmaceutical Research and Manufacturers of America (PhRMA)
U.S. Food and Drug Administration, Center for Drug Evaluation and Research (FDA/CDER)

New Member Organizations:
International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)
United States Pharmacopeia (USP)

Board of Directors

Robert Lipper, Ph.D., Chair (AAPS)

Alexander Giaquinto, Ph.D., Treasurer (AAPS)

Gordon Hansen (IPAC-RS)

Mary Oates (PhRMA)

Avraham Yacobi, Ph.D. (AAPS)

PQRI Steering Committee (representative and alternate):

Chair

Gordon Hansen, IPAC-RS

AAPS

Mario Rocci, Ph.D., John Lisack, Jr.

CHPA

Frederick Razzaghi, Chris Allen

FDA

Helen N. Winkle, Nakissa Sadrieh, Ph.D.

IPAC-RS

Jeffrey Blumenstein, Ph.D., Mary Devlin Capizzi, J.D.

IPEC-Americas

Ashok Katare, Ph.D.

PDA

Richard Levy, Ph.D., Gail Sherman

PhRMA

Scott Boudreau, Ph.D., Mary Oates, Ph.D.

USP

Ronald Manning, Todd Cecil, Ph.D.

 
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