PQRI facilitates educational workshops and programming on projects related to the Institute’s vision and mission.
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). Registration to open in mid-December 2024. 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. If you missed the workshop and would like access to the Workshop recordings, please complete this registration for access (for a nominal fee).
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
If you are having problems viewing the PDF documents or they open to a blank page, please reference this article for assistance.