On October 5 – 7, 2015, FDA and PQRI hosted a public conference “2nd FDA/PQRI Conference on Advancing Product Quality.”  This Conference brought together regulatory, academic, and industry experts.  Inputs from attendees will aid in future FDA guidance development.

Day 1 began with plenary lectures.  Attendees then broke into four themed concurrent sessions for the rest of Day 1 and Day 2: 

                 1) Emerging Regulatory Topics

                2) Regulatory Submission, Assessment and Inspection

                3) Product and Process Development and

                4) Manufacturing, Risk Management and Quality Assurance.

The third day began with a summary of the sessions and ended with a Roundtable with FDA leaders.

FINAL PROGRAM

Click here to view the Final Program. 

PRESENTATIONS

Click here to access the presentations.

REPORT

The report from the 2nd FDA/PQRI Conference has been published in The AAPS Journal, DOI 10.1208/s12248-016-9874-5.

QUESTIONS

Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.