Conformia Biotech Working Group to Convene in Washington, DC
Published: Nov 14, 2008
WASHINGTON--(BUSINESS WIRE)--Conformia: What: Senior thought leaders from seven of the major biotech and pharmaceutical companies will convene in Washington, DC next week to discuss future drug development paradigms in light of the new ICH Quality Vision. Specifically, teams representing each company will attempt to create a future state of what the development approaches will look like under a Quality by Design (QbD) paradigm as well as the regulatory implications that would result. The Chemistry Manufacturing and Controls (CMC) Biotech Working Group is led by Conformia and is a not-for-profit effort through the FDA-Conformia Cooperative Research and Development Agreement (CRADA), which is focusing efforts to help the industry meet the goals of the FDA's QbD initiative.