Janet Woodcock, MD, Director, CDER, FDA has been confirmed as the keynote presentation at the 2008 PDA/FDA Joint Regulatory Conference. She will join speakers EMEA, SHFDA and USP for the Opening Plenary Session. Learn more »

The US Food and Drug Administration (FDA) announced the Good Manufacturing Practices (GMPs) for the 21st Century initiative in 2002, giving the industry its first glimpse of the future of regulatory oversight for pharmaceutical production. The intent of the original initiative was to offer the industry the necessary tools to provide more post-approval flexibility, making continual improvement less of a regulatory burden, and to promote better self-regulation to improve regulatory compliance status.

In the five years that have passed since the announcement, regulatory health authorities and industry have partnered by harmonizing requirements and implementing new systems for assuring and maintaining pharmaceutical quality. The 2008 PDA/FDA Joint Regulatory Conference will provide examples of how these new approaches have been successfully implemented.  In addition, the conference will examine what is working well and where the industry and regulatory health authorities still need to work to achieve modernized quality systems.