Building a National Framework for the Establishment of
Regulatory Science for Drug Development
February 26, 2010
National Academy of Sciences (NAS) Building
Lecture Room
2101 Constitution Avenue, NW
Washington, DC 20418
With the advent of emerging technologies and a national focus on drug safety, the need for sound science to make good regulatory decisions is more urgent than ever. Every day, a gap widens between the scientific developments in areas that are relevant to FDA and its ability to meet each innovation and simultaneously regulate products that make up 25% of the U.S. economy. Despite the importance and necessity for a regulatory foundation in quality science, there also exists a gap in understanding between the public, policymakers, and the agency on what is required to carry out such a task.
To address these concerns, the IOM Drug Forum will convene a public workshop to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. This workshop will provide an opportunity to fully explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, and consider alternative mechanisms and institutional frameworks for its development and application in regulatory management. It will feature experts on the science of drug regulation, as well as stakeholders in drug development and the regulatory process, including representatives of patient groups, academia, government, and industry.
A range of approaches and innovative mechanisms will be considered:
- fostering the scientific discipline of regulatory science;
- promoting closer collaboration between of regulatory and academic researchers;
- regulatory science centers of excellence; and
- medical education and professional development programs.
If you would like to a submit a comment or question for the moderated discussion at the end of a panel, please use our online form. Comments will only be accepted through the web form until February 25, 2010, at 5pm EST.