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Legal and Compliance Considerations for Engaging Patients As Partners

Gain knowledge of how to successfully incorporate ethical, legal, and regulatory requirements into your patient engagement activities.

Authors

K. Kimberly  McCleary

K. Kimberly McCleary

Founder and Chief Executive Officer, The Kith Collective, LLC, United States

Kim McCleary has been at the forefront of patient engagement for more than 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications, served on dozens of steering committees and advisory boards, is a sought-after speaker, and has an extensive network of leadership contacts. Her passion for this work is rooted in personal experience, lived and as a family caregiver. To speed adoption of patient-centricity by life science companies, not-for-profit organizations, and academic research teams, in early 2018 Kim established a professional services firm, The Kith Collective, LLC.

Suzanne  Schrandt, JD

Suzanne Schrandt, JD

Founder, Chief Executive Office and Chief Patient Advocate, ExPPect, United States

Suz Schrandt, JD, is Patient Engagement Director at the Arthritis Foundation. She was previously Deputy Director, Patient Engagement for PCORI, where she helped to launch key efforts including the Engagement Rubric. Schrandt's patient engagement focus stems from her own rheumatological diagnosis at age 14. Prior posts include roles in health and disability law and policy, genetics, and public health. Schrandt is chair of the ISPOR Patient Roundtable and a member of the FDA’s PEAC.

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