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Millennium Gloucester Hotel London Kensington

Sep 23, 2014 9:00 AM - Sep 24, 2014 5:30 PM

4-18 Harrington Gardens, London, SW7 4LH, United Kingdom

8th Annual European Medical Information and Communications Conference

Session 6: INFORMATION TO PATIENTS IN THE EUROPEAN UNION

Session Chair(s)

Lillian  Auberson, PhD

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)

Juan  Garcia-Burgos, MD, PhD

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

D.K.Theo  Raynor, PhD, MPharm

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

Jan  MacDonald, MSc, RPh

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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