Definition

Documents or tools designed to inform healthcare professionals and/or patients about specific risks and how to minimize them.

Example

Educational materials for an injectable drug include: HCP guide on injection technique and monitoring, patient guide on self-administration, and injection site reaction management.

Regulatory source

EU GVP Module XVI

Common mistakes

Creating materials that are too lengthy or complex for the target audience to use effectively.

Inspector question

How do you develop and test educational materials? How do you ensure they reach the target audience?

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