After working to harmonize technical requirements under the ICH, establishing confidentiality arrangements, collaborating on inspection pilots, exchanging working level scientific and regulatory policies, procedures, and reports, and implementing technical level "clusters" of agency reviewers ....what are the next challenges and next steps in 21st century regulatory cooperation?

In this session, the audience will be privileged to hear views from the leaders of three of the most influential drug regulatory agencies — Health Products and Food Branch of Health Canada, the European Medicines Agency, and the US FDA—on these important issues.

How do agencies meet their domestically-focused mission in an increasingly global environment?

What will regulatory collaboration look like as we go further into the 21st century?

How do you integrate local community perspectives and needs into efforts to increase collaborative efforts with other agencies to innovate public health worldwide?

How does an agency share international values with its primarily local constituents, especially parliamentary overseers?

Learning Objectives:
Discuss the status of the continuing exchange of information and personnel among regulatory agencies
Describe current strategic thinking and knowledge gained by regulators through joint projects and actions
Identify from audience feedback to regulators about impact on industry operations.