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Session 4: Drug/Device Company Interactions with Patient Advocacy Groups: Working Collaboratively and Compliantly
Session Chair(s)
Joanne Hawana, JD, MS
Member, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
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.
Learning Objective : - Develop an understanding of the benefits & value of involving patients & caregivers in the drug & medical device development process
- Recognize potential regulatory risks for unapproved & approved medicinal products when Sponsors interact with patient advocates, patients & caregivers
- Evaluate degree of risk to involve appropriate SMEs when creating new programs and risks in collecting data from patient advocacy groups & their members
Speaker(s)
Moderator
Member, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Panelist
Vice President, Government Affairs & Patient Advocacy, Mallinckrodt Pharmaceuticals , United States
Panelist
Director, Hyman Phelps & McNamara P.C., United States
Panelist
Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States
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