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Mercure Hotel Amsterdam City

04 dic 2019 8:00 a.m. - 05 dic 2019 5:00 p.m.

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 7: Lay Summaries and Regulatory

Session Chair(s)

Caragh  Murray

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

User Testing Perspective

D.K.Theo Raynor, PhD, MPharm

University of Leeds, United Kingdom

Professor of Pharmacy Practice

Anne  Cutting

Industry Perspective

Anne Cutting

GSK, United Kingdom

Director, Human Subject Research Governance

Tomas  Rees, PhD

Medical Writing Perspective

Tomas Rees, PhD

Oxford PharmaGenesis, United Kingdom

Communications Director

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