At the inaugural joint FDA/ISPE conference on CGMP earlier this year, CDER Dirctor Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt QbD principles must be a top priority. Woodcock put the onus on industry and regulators to find ways to work together more effectively, to engage in productive conversations, and to dissolve roadblocks to QbD and the issues that can lead to counterfeiting and drug shortages.
ISPE has made pharmaceutical quality a keystone of its new direction and focus. The industry needs a holistic approach, one that considers the entire product lifecycle, if it is to move past legacy issues and get ahead of the curve in terms of manufacturing best practices. That is the mission ISPE has aligned behind, and it is the mission that has shaped the conference program for the upcoming 2012 ISPE Annual Meeting, taking place on November 11–14 in San Francisco, CA.
A key element of ISPE's mission is greater interaction between pharmaceutical professionals and global regulators responsible for ensuring drug safety. We have assembled an impressive number of regulators from every major international pharmaceutical market—North America, Europe, Asia, and Latin America—for an International Regulatory Summit. The summit will feature a discussion on regional regulatory challenges and an examination of those challenges within the context of a global regulatory environment.Since I joined ISPE as its CEO earlier this year, I have been impressed by the degree to which our members are willing to work together on finding solutions to technical issues. ISPE's renewed focus means that we must bring those open conversations to ever-larger audiences in ever-more-visible ways. At our 2012 Annual Meeting, our Executive Program Series will put these conversations on a global stage.
Dr. Woodcock's words at the CGMP event did not fall on deaf ears; ISPE and its members understand that change for pharmaceutical manufacturing is long overdue. Our 2012 Annual Meeting program is designed to give the industry the tools it needs to foster global change.