Regulatory Affairs is many times seen as one of the most technical and operational areas in the industry: we develop strategic regulatory plans, drive crucial input to R&D teams and maintain industries compliant. Still, despite all these regulatory contributions to patient access and care, direct contact between regulatory functions and patients tends to lack, when compared to other customer-facing functions such as Medical or Public Affairs. Despite that, regulatory authorities and developers have given great strides in advancing how patient experience and input is translated to tangible, regulatory outcomes, such as labels: in the US, “patient experience data” (PED), or the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients, has since 2016 been included in FDA reviews, and other regulators globally are also improving they way they listen to patients and review patient-reported evidence or outcomes in the evaluation of new medicines. How can regulatory affairs professionals be key difference makers in translating patient preference data into meaningful outcomes that can drive better access and care to patients globally? How can regulatory affairs professionals strategically look at evidence generation plans and push for a bigger role in patient preference? In this session we will discuss the current status of the matter and how industry and regulators have set best practices in making patients key partners in drug development and evaluation.
Better understand the patient role in modern drug development and evaluation, particularly on regulatory activities and medicines evaluations.
Explain background on, and status of, patient initiatives like the FDA's implementation of 21st Century Cures requirements to convey FDA's consideration of patient experience data, amongst others.
Discuss and learn from different stakeholders what it means to be a patient-centric regulatory professional.