Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCPs

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What is this Webinar About?
Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all.

In this second presentation of our Deep-Dive: Plain Language Writing webinar series, we focus on best practices that guide the development of common forms of plain language communication intended for the patient, their families and/or caregivers, such as the:
• Patient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD)
• Plain Language Summary (PLS) of a published journal article
• Lay summaries required under EU CTR for clinical trials on medicinal products

Webinar Learning Objectives:
Join us as we discuss practical strategies you can use to develop effective patient-centered lay summary content such as:
Who: Identify the target audience and the details and demographics of who they are.
Why: Why does the audience need to know the information?
What: What are the goals of providing the content, e.g., for information only, to spur action, or fulfill a regulatory requirement? What format is best suited to support the desired message and goal?
How: Identify the most appropriate dissemination channels for the information and any audience accessibility considerations.
When: Determine any relevant timing strategies or requirements, e.g., regulatory deadlines.

Speaker:
Laurie Mitchell
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.