3rd FDA/PQRI Conference on Advancing Product Quality
On March 22-24, 2017, FDA and PQRI hosted a public conference the “3rd 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.
Days 1 and 2 began with plenary lectures. Attendees then broke into three themed concurrent tracks for the rest of Day 1 and Day 2:
- Track #1: Drug Classification, Release, and Modeling for Setting Clinically Relevant Specifications
- Current and emerging thinking on biowaivers, predictive dissolution, drug release and modeling, and biopharmaceutics classification system for topical drug products.
- Track #2: Achieving Drug Product Quality: Novel Approaches and Applications
- Advancing dialogue on combination product quality and bioequivalence, extractables/leachables issues in novel applications, and current thinking on oligonucleotide quality risk management and manufacturing.
- Track #3: Enhancing Product Quality through Continuous Manufacturing
- Holistic overview of continuous manufacturing, with an assessment of “where we are now” and “where are we heading,” and continuous manufacturing case studies addressing API, Drug Product, barriers and opportunities.
Day 1 and Day 2 Plenary Sessions and Day 3 Roundtable: On Day 1 and Day 2, attendees heard FDA present on an Office of Pharmaceutical Quality Progress Update, Clinical Relevance: Connection, Context and Collaboration, and the Future of Pharmaceutical Quality and the Path to Get There. Additional plenary topics included: ICH Q12: A Unique Opportunity to Realize 21st Century Quality Vision, Opportunities for Standardization in Continuous Manufacturing and PQRI: A Strong Foundation to Embrace and Engage Change. Day 3 included Summaries of the three tracks and and a Roundtable on Global Harmonization with FDA, EMA, PMDA and Industry leaders.
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.