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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)
D.K.Theo Raynor, PHD, MPHARM
Professor of Pharmacy Practice, University of Leeds, United Kingdom
User Testing Perspective
Anne Cutting
Director, Human Subject Research Governance, GSK, United Kingdom
Industry Perspective
Tomas Rees, PHD
Communications Director , Oxford PharmaGenesis, United Kingdom
Medical Writing Perspective