Feature articles over the past weeks have focused on risk management, the global regulatory framework, including next generation cancer vaccines, drug delivery combinations and pediatric plans, the latest on EU MDR and EU IVDR implementation and global orphan drug regulations.
Risk Management
Recognized drug safety and risk management expert Elaine Morrato discusses the intersection of emerging implementation science and regulatory science innovation and how together they may advance pharmaceutical risk management in the US. In Pharmaceutical Risk Management in the 21st Century Cures Era, the author touches on risk management as an adaptive, rapid-cycle process embedded within a learning health system; dissemination design for better adoption and sustainability of the intended…