Program Overview
This practical, high-impact course is designed for medical and regulatory writers who need to create patient-facing content for clinical trial transparency. Covering EU CTR 536/2014 requirements and global trends, the program blends regulatory knowledge, plain language principles, and hands-on writing practice. Participants will learn to simplify complex trial data, enhance readability with tools and visual aids, and integrate patient feedback while maintaining compliance. With templates, checklists, and expert guidance, this course ensures writers can confidently deliver transparent, accessible, and ethically sound lay summaries.
Features
- Understand global regulatory requirements for lay summaries.
- Apply plain language, readability, and health literacy best practices.
- Structure clear, compliant, and patient-friendly clinical trial summaries.
- Use readability tools and patient feedback to refine communication.
Target audiences
- Beginner–Intermediate medical writers/Transparency writers
- Regulatory writers working on EU submissions
- Clinical writers exploring patient-facing deliverables
- Pharma comms professionals writing trial disclosures
- Medical affairs writers creating educational content
Curriculum
- 6 Sections
- 18 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Regulatory Foundations3
- Principles of Plain Language3
- Writing Techniques for Lay Summaries3
- Tools and Technologies3
- Patient-Centric Review and Feedback3
- Practice and Assessment3
Instructor
