Conference: EMWA Spring Conference 2026
Date: May 5 - 8, 2026
Location: Barcelona, Spain
Where to hear Certara insights and expertise
Presenter: Claire Dyer
This session introduces participants to the preparation of clinical submission dossiers in accordance with the Common Technical Document (CTD). It outlines the general principles and processes of summary writing, with a focus on developing clear, structured, and regulator-focused clinical summaries. The session will also explore the limits of available regulatory guidance and discuss how to apply professional judgment when preparing global submissions.
Claire Dyer
Director of Submissions and Medical WriterClaire Dyer is a director of submissions and medical writer with experience in multidisciplinary clinical, academic, and corporate environments. She has 20 years of experience in clinical development, including 15 years in medical writing and experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND) and Clinical Trial Authorisation (CTA) applications. Claire has led submission teams, including project management, writing submission level documents as well as training and mentoring of junior writers. Her interest in the field of oncology has continued since her PhD in adoptive T cell therapy for lymphoma.
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