The new exchange will provide the two agencies with a forum to discuss best practices regarding the manner in which each agency engages patients through the development, evaluation and post-authorization tracking of medicines. Future talks on patient engagement will include examination of the processes by which patients are selected and prepped for participation in the activities of the respective agencies.
“It is important to engage [patients] to be able to fully understand their needs and priorities and make their voice heard along a medicine’s lifecycle. Many of the challenges and benefits of working with patients are similar for both regulators. We look forward to increasing our collaboration with FDA in this area in order to benefit from each other’s experiences, and to advance patient involvement,” said Guido Rasi, MD, executive director of the EMA.
The two regulatory agencies also hold regular teleconferences on a multitude of topics including blood products, vaccines and oncology-hematology products.
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