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Session 7: Lay Summaries and Regulatory
Session Chair(s)
Caragh Murray
Plain Language Summary Manager, Data Transparency
Janssen Research & Development, United Kingdom
Lay Summaries are required for all studies sponsors will run in the EU after the EU CTR effective date. Sponsors have begun implementation and many early successes have led to lessons learned in delivery. In this session sponsors with different perspectives will present their experiences to date through a panel discussion. Objectives: •Discuss experience in the implementation for each sponsor •Share lessons learned during the implementation as early adopters •Discuss key topics that have presented a challenge during the implementation •Discuss current hot topics sponsors are facing during their implementation journeys
Speaker(s)
User Testing Perspective
D.K.Theo Raynor, PhD, MPharm
University of Leeds, United Kingdom
Professor of Pharmacy Practice
Industry Perspective
Anne Cutting
GSK, United Kingdom
Director, Human Subject Research Governance
Medical Writing Perspective
Tomas Rees, PhD
Oxford PharmaGenesis, United Kingdom
Communications Director
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