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Information on Medicines for Lay Audiences
Session Chair(s)
Melanie Carr
Head of Stakeholders and Communication Division
European Medicines Agency, Netherlands
D.K.Theo Raynor, PHD, MPHARM
Professor of Pharmacy Practice
University of Leeds, United Kingdom
We live in the era of transparency and communication, where it has never been easier for lay people to find information related to health and medications. However, patients still struggle to find reliable information which is easy to understand. While improvements have been made in the past, many challenges still remain to be addressed and this session will explore these.
Learning Objective : 1. Describe the regulations requiring clinical trial results lay summaries. 2. Understand the draft guidance on writing the summaries and the insight from user testing. 3. Implement the guidance developed to support the regulation.
Speaker(s)
The Challenges of Health Literacy
Michael S. Wolf, PHD, MA, MPH
Institute for Public Health and Medicine, United States
Professor, Medicine, Northwestern Medicine; Associate Vice Chair for Research
Information for Patients from Regulatory Authorities – The EMA Experience
Juan Garcia-Burgos, MD, PHD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Clinical Trial Results for Laypersons - Implementing the Guidance
D.K.Theo Raynor, PHD, MPHARM
University of Leeds, United Kingdom
Professor of Pharmacy Practice
Panel Discussion
Kaisa Immonen
European Patients' Forum, Belgium
Director of Policy
Panel Discussion
Thomas Schindler, PHD
BioNTech SE, Germany
Director Global Regulatory Affairs - Regulatory Operations