The Interpretation of Guidances & Regulations Initiative shares expertise to more efficiently and effectively meet the intent of what are historically ambiguous regulations, guidances and operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-world impact of ambiguous regulations and guidelines. While addressing these aims, the initiative will consider the highest priority to be the continued enhancement of patient safety. The resources below were developed as part of their mission to share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.