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PQRI Events

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


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

4th PQRI/FDA Conference on Advancing Product Quality:  Patient-Centric Product Design, Drug Development, and Manufacturing  


April 18-19, 2018

PQRI PODP Extractables & Leachables (E&L) Workshop


November 2-3, 2017 

3rd PQRI/USP Workshop on ICH Q3D Elemental Impurities Requirements – Recent Experience and Plan for Full Implementation in 2018


March 22-24, 2017

3rd FDA/PQRI Conference on Advancing Product Quality


 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

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

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

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