ARC CEO Named Representative of Patient Engagement Collaborative
To strengthen patient involvement, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced the launch of the Patient Engagement Collaborative (PEC).
PEC is comprised of external patient community stakeholders who could offer their experiences and perspectives on patient engagement in FDA’s regulatory processes. ARC CEO, Isabelle Lousada, is among a small and auspicious group of patient experts invited to be a member.
“I am honored to have been invited to be an inaugural member of the newly formed FDA Patient Engagement Collaborative (PEC).” Says Lousada, “Patient engagement plays a critical role in addressing and supporting the FDA’s ongoing commitment to better serve the patient community and incorporate the perspectives of patients into the FDA regulatory decision-making processes.”
This new Collaborative is also facilitated by provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017. Both provisions aim to foster patient participation and incorporate patient experiences in the regulatory process.