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