The Investigational Medicinal Product Dossier or IMPD contains summaries of information related to the quality, manufacture, and control of any IMP, along with data from non-clinical and clinical studies, including the overall benefit and risk assessment.
The IMPD is a critical part of the European clinical trial application, as the clinical trial may not be approved if significant issues are identified with the chemistry, manufacture, and controls information. To avoid potential non-approval issues, it is imperative that the initial IMPD submission be comprehensive and of high quality.
Allucent’s A-team experts give three tips for IMPD success.
