PQRI facilitates educational workshops and programming on projects related to the Institute’s vision and mission.
REGISTRATION IS OPEN. Register by January 31st to save $250. FDA/PQRI Workshop – 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 (Bethesda, MD). Click here for details.
PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop – GBHI 2024 – An In-Person event was held on April 16-17, 2024 at USP in Rockville, Maryland, US. Click here for more details.
FDA/PQRI Workshop: Challenges and Opportunities for Modified Release Oral Drug Product Development – A Forum for Stakeholder Engagement – An In-Person event was held on April 18, 2024 at USP in Rockville, Maryland, US. Click here for more details.
PQRI Workshop: MIDD Approaches in Pediatric Formulation Development – A Virtual event was held on February 28-29, 2024. Click here for more details.
FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing – An Opportunity for Stakeholder Engagement A Virtual Event was held on September 26-27, 2023. Click here for more details.
PQRI Workshop: TiO2 Use in Pharmaceuticals – Global Regulatory and Technical Challenges, a Hybrid Event, was held on June 13-14, 2023 at the Bethesda Marriott. Click here for more details and to view the Workshop Summary.
FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
A Virtual Event was held on November 14-16, 2022 Click here for more details.
PQRI Workshop: Managing Excipient and API Impact on Continuous Manufacturing, a Virtual Event was held on May 17 – 18, 2022. Click here for more details.
5th PQRI/FDA Conference on Advancing Product Quality: Advancing Quality & Technology of Future Pharmaceuticals Virtual Event was held on December 1 – 3, 2021.
PQRI Webinars scheduled through 2022. Recordings from past webinars (2018-2022) are available for viewing at this link.
November 9-10, 2020 VIRTUAL EVENT
4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements
April 9-11, 2019, Rockville MD
April 18-19, 2018
PQRI PODP Extractables & Leachables (E&L) Workshop
November 2-3, 2017
March 22-24, 2017
3rd FDA/PQRI Conference on Advancing Product Quality
November 9-10, 2016
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
Breakout Session I Summary: Assessment of Ingredients – Excipients and APIs
Breakout Session II Summary: Analytical Testing Considerations
Breakout Session III Summary: Successful Risk Assessment Methodologies
Breakout Session IV Summary: Finished Dosage Form Considerations
September 16-17, 2014
1st FDA/PQRI Conference on Evolving Product QualityFinal Program Agenda
September 11 – 12, 2011
PQRI Workshop on Sample Sizes for Decision Making in New Manufacturing Paradigms–Agenda (PDF)
April 29-30, 2010
Coordinated PQRI Workshop with RDD 2010 on Addressing the Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products – Flyer (PDF), Agenda (PDF)
For additional information on both meetings go to RDD Online
RDD/PQRI Speakers Presentations
January 14-15, 2014
PQRI Workshop on Nanomaterial Drug Products
USP Meeting Center
Rockville, MD – Agenda (PDF)
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
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