The Regulatory Affairs and Submissions Track incorporates local and global topics pertaining to development, submission, approval, and beyond. This track emphasizes regulatory trends, strategic regulatory issues and practices, and tactical issues that affect the regulatory process.

At the conclusion of this meeting, participants should be able to:
• Discuss the latest global regulatory trends and developments that impact the industry
• Recognize key issues associated with evolving regulatory standards

**Please note workshops that were made available during the Annual Meeting included attendee interactivity. Due to such format, audio recordings may not be available.