Best practices for the process of characterizing the ongoing safety profile of a compound starting from clinical development through the post-marketing phase will be discussed. In particular, the processes, strategic considerations, endpoints, measures and methods found to be most effective for monitoring and evaluating aggregated safety data, and creative ways to display and communicate the safety profile will be discussed. Participants will be encouraged to share their experiences and insight about effective and innovative approaches for ongoing aggregate safety evaluation (OASE) that will ultimately help to inform the emerging safety profile of a compound.