Advertising and Promotion Regulatory Affairs Conference

Over the past decade, the shift to patient-focused drug development, as well as the increasing reliance on real-world evidence to support regulatory applications for both drugs and devices, has elevated the importance of ensuring that Sponsors have strong relationships with patients and their advocates, ranging from caregivers to formal advocacy and educational groups. However, those relationships are often fraught with regulatory and compliance risks if communications between sponsors and patients/advocates about investigational products become promotional in nature, items of significant value are involved in the interaction, or protected health information is being collected, among other considerations. This session will allow for a candid discussion of potential pitfalls in the continuously evolving communications between Sponsors and patient groups, and share tips for how to avoid them in both the pre-and post-market settings.