EDG: High‐impact but Low‐visibility: Nonclinical Summary Writing for CTD Module 2

Description

This Expert Discussion Group (EDG) focuses on the writing of nonclinical summaries for CTD Module 2, an area of high and increasing demand as sponsors increasingly rely on CROs and freelance medical writers. Targeted at writers experienced in nonclinical CTD sections, the EDG provides a practical exchange forum to address real‑world challenges arising from heterogeneous data packages and poor‑quality source documents for example. Core discussions will cover structure, level of detail, interpretation, and regulatory expectations across ICH regions. The EDG will also explore managing and training IND submission teams, including scoping work, estimating effort, and developing cost proposals, to support high‑quality and efficient nonclinical submissions.