For drugs in development, sponsors must consider the use or potential use of the drug in a pediatric population. Successful pediatric regulatory strategies can be complex. Lack of harmonization in regulatory requirements and challenges in developing a robust pediatric global strategy can result in not only a delay in approval adversely impacting patients but also increased costs. Although there are many similarities, differences exist and knowing these differences is critical to developing a successful regulatory strategy. The workshop will explain the US, EU, and Japan pediatric drug development requirements and address key challenges in an evolving regulatory landscape. This workshop will engage participants through mock development of pediatric strategies, identifying regulatory risks and approaches to mitigate those risks. The workshop also will discuss the need for alliances with patient representatives and patient advocacy groups.