Pharmacovigilance and Risk Management Strategies Conference

A systematic approach to quality is essential to meet legal obligations for monitoring medical product safety and for protecting patient safety. To facilitate oversight of this requirement and to ensure that a marketing authorization holder (MAH) meets its legal obligations for monitoring the safety of its products, the EU first defined the requirement for a responsible person, termed a Qualified Person for Pharmacovigilance (EU QPPV) in Directive 2001/83/EC (Art 104). Over time, other regulatory jurisdictions have extended this concept, i.e., an individual person who serves as the single focal point with responsibility for oversight of various aspects of the structure, performance, and maintenance of the MAH’s local, regional or global pharmacovigilance system. The title of the role differs across regions as do its responsibilities and legal obligations; this non-harmonized approach requires a thoughtful approach to managing the relevant global requirements. This session provides a high-level snapshot of the changing global landscape, followed by a panel discussion with perspectives on pragmatic approaches for efficient organizational and operational solutions as the role of the responsible person evolves.