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Session 6: INFORMATION TO PATIENTS IN THE EUROPEAN UNION
Session Chair(s)
Lillian Auberson, PhD
DIrector Medical Information EMEA
Argenx Switzerland SA, Switzerland
Learning Objective : 1. Describe the key principles to apply when preparing regulatory documents for a lay readership. 2. Explain the differences between the information needs of professionals and lay people in relation to regulatory documents. 3. Formulate RMP Summaries which take account both of the GVP guidance and best practice in information writing and design for lay people. 2 3
Speaker(s)
Information to Patients and Healthcare Professionals: Update from the EMA
Juan Garcia-Burgos, MD, PhD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Risk Management Plan Lay Summaries - How to Make them fit-for-purpose
D.K.Theo Raynor, PhD, MPharm
University of Leeds, United Kingdom
Professor of Pharmacy Practice
Providing Benefit Information in Patient Leaflets - Can it be done and what do Patients think?<br>(on behalf of Rebecca Dickinson, Lecturer, School of Healthcare, University of Leeds, UK)
Jan MacDonald, MSc, RPh
MHRA, United Kingdom
Group Manager for AIMS
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