Chemistry, Manufacturing, and Controls 2011 Summit

May 10, 2011

Workshop

Location: Philadelphia, Pennsylvania

IQ Consortium CMC Leadership Groups met in Philadelphia on May 10, 2011, where Leadership Group members gave presentations on potential areas of focus and deliverables for Contract Manufacturing For API and DP (DPLG, ALG, and APILG), Phase-Appropriate GMP Expectations (DPLG and ALG), Business Cases and Best Practices to Advance Manufacturing Innovation, PAT and RTR (ALG, DPLG, and API LG). Leadership Group members also presented on potential areas of focus and deliverables for API Starting Materials, Radiolabelled Materials, Excipients, Import/Export and PLAIR, and Green Chemistry.
Participants met to further discuss and agree on preliminary strategies and deliverables for the topics discussed earlier in the day (neither Radiolabelled Materials nor Green Chemistry had a breakout session). Summaries of these sessions, which were submitted by Working Group leaders after the meeting, are included in the attached slides.