Clinical Trials Workshop

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.There will be a particular focus on the critical issues affecting sponsors and Member States as they consider the impact and changes needed to implement the regulation.

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Session 6 Panel discussion on lay summaries: How can we meet patients’ expectations?

Session Chair(s)

Sini Eskola, MPharm, MS, MSc

Director Regulatory Affairs

EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

During this session, patient representatives will be invited to share their expectations for the lay persons’ summary. Relevant stakeholders from industry, EMA and MS will be asked to reflect on this and share their current thinking to ensure optimization of information to be provided to the patient.

Speaker(s)

Antonio Ferrari, MD, MBA

Erydel S.p.A., Italy

Global Medical Director

Amanda Hunn, MA

AJ Hunn Associates, United Kingdom

Self-employed Advisor/Formerly Head of Policy and Public Affairs At the HRA

Marleen Kaatee

PSC Patients Europe, Netherlands

President

Lidia Retkowska-Mika, LLM

Office For Registration of Med. Products, Medical Devices and Biocides, Poland

Director Legal DPT

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