Overview
There are already well-established procedures and contracting processes for engaging academic and medical experts in the work of life science companies based on accumulated experience. However, other groups, such as patients, care partners, and patient advocates, bring different expertise and expectations. Legal and compliance considerations are an important part of the patient engagement process and apply to interactions with patients, care partners, and patient advocacy organizations (PAOs). Having an established understanding of these considerations and the regulatory processes that govern them will benefit your company, the employees who engage with patients, and the patient participants themselves..
This module covers key legal, ethical, and regulatory requirements for working with patients, care partners, and patient advocates throughout the medical product development lifecycle and provides practical guidance and examples for productive, mutually beneficial engagement with patients as partners. Specific areas discussed include fair practices for engaging patients, care partners, and patient advocates, including non-disclosure, privacy, compensation, non-exclusivity, and independence. While the module contains information helpful to individuals in any region, many of the specific details focus on emerging practices and policies in the United States and Europe.
This module takes an average of 2.5 hours to complete.
This module is part of the DIA Patient Engagement eLearning Program and a component of the Patient Engagement Certificate Program.
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