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.
The report from the 2nd FDA/PQRI Conference has been published in The AAPS Journal, DOI 10.1208/s12248-016-9874-5.
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.