FDA Chats about Drug Quality, Innovation and What Drives Them Forward

Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Three representatives from FDA—Michael Kopcha, Sau Lee, and Cindy Buhse—join Chris Spivey, editorial director, for a discussion about 1) emerging technology programs; 2) the framework for regulatory advanced manufacturing evaluation; 3) quality management maturity ratings; 4) quality of pharmaceuticals and its relatability to other variables, such as economics; 5) continuous vs. batch manufacturing; 6) pandemic pressures and improved communication; 7) keeping up with biotech and emerging therapies; and 8) what manufacturers need to know. SPEAKERS: Michael Kopcha, PhD, R.Ph., director of the FDA’s Office of Pharmaceutical Quality (OPQ); Sau Lee, PhD, deputy director of science, Office of Pharmaceutical Quality, CDER at FDA; Cindy Buhse, PhD, deputy director of operations, Office of Pharmaceutical Quality, CDER at FDA SPONSOR: Samsung Biologics